Pub Date : 2026-01-01Epub Date: 2025-11-12DOI: 10.1097/CCM.0000000000006949
Julia A Heneghan, Kailash R Velusamy, Sriram Ramgopal, Denise M Goodman, Michael D Evans, Madhura Hallman, Alexandra Feldman, Manzilat Y Akande
Objectives: To identify and describe trajectories of functional status in children with repeated PICU admissions and to describe clinical and demographic characteristics of each trajectory.
Design: Retrospective, cross-sectional study.
Setting: Twenty-four U.S. PICUs participating in the Virtual Pediatric Systems, LLC database.
Patients: Patients younger than 21 years old discharged from an index admission between April 2017 and December 2020, followed through December 2022.
Interventions: None.
Measurements and main results: Functional status, a multidimensional marker of a child's physiologic and cognitive status, was measured using the Functional Status Scale (FSS). FSS scores were collected by trained abstractors to reflect pre-illness baseline and status at PICU discharge for each encounter. We performed latent trajectory analysis to examine longitudinal patterns in patient FSS categories and identify trajectory classes, with classes selected by the minimum Bayesian Information Criterion. We performed Kruskal-Wallis rank-sum test and chi-square testing to assess differences between groups. The analytic cohort included 6038 children with greater than 1 PICU encounter. Using a linear trajectory model, we identified six latent classes: three stable over time (good [46.6%], moderate [18.7%], and severe dysfunction [15.5%]), two with worsening over time (good/mild dysfunction with significant decline [7.9%], good/mild dysfunction with moderate decline [5.7%]), and one with improvement over time (mild dysfunction with improvement [5.6%]). In univariable analysis, trajectory classes differed based on age, race and ethnicity, diagnosis category, procedural exposure, severity of illness, and length of stay for the index admission. These associations were also present when assessed using multinomial regression and random forest classification.
Conclusions: In this multi-institutional database study using FSS scores to describe a contemporary, heterogeneous patient population with recurrent PICU-based observations of functional status, we identified six classes of outcome trajectories with different clinical and demographic characteristics.
{"title":"Latent Classes in Long-Term Functional Status in Children With Recurrent Critical Illness.","authors":"Julia A Heneghan, Kailash R Velusamy, Sriram Ramgopal, Denise M Goodman, Michael D Evans, Madhura Hallman, Alexandra Feldman, Manzilat Y Akande","doi":"10.1097/CCM.0000000000006949","DOIUrl":"10.1097/CCM.0000000000006949","url":null,"abstract":"<p><strong>Objectives: </strong>To identify and describe trajectories of functional status in children with repeated PICU admissions and to describe clinical and demographic characteristics of each trajectory.</p><p><strong>Design: </strong>Retrospective, cross-sectional study.</p><p><strong>Setting: </strong>Twenty-four U.S. PICUs participating in the Virtual Pediatric Systems, LLC database.</p><p><strong>Patients: </strong>Patients younger than 21 years old discharged from an index admission between April 2017 and December 2020, followed through December 2022.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>Functional status, a multidimensional marker of a child's physiologic and cognitive status, was measured using the Functional Status Scale (FSS). FSS scores were collected by trained abstractors to reflect pre-illness baseline and status at PICU discharge for each encounter. We performed latent trajectory analysis to examine longitudinal patterns in patient FSS categories and identify trajectory classes, with classes selected by the minimum Bayesian Information Criterion. We performed Kruskal-Wallis rank-sum test and chi-square testing to assess differences between groups. The analytic cohort included 6038 children with greater than 1 PICU encounter. Using a linear trajectory model, we identified six latent classes: three stable over time (good [46.6%], moderate [18.7%], and severe dysfunction [15.5%]), two with worsening over time (good/mild dysfunction with significant decline [7.9%], good/mild dysfunction with moderate decline [5.7%]), and one with improvement over time (mild dysfunction with improvement [5.6%]). In univariable analysis, trajectory classes differed based on age, race and ethnicity, diagnosis category, procedural exposure, severity of illness, and length of stay for the index admission. These associations were also present when assessed using multinomial regression and random forest classification.</p><p><strong>Conclusions: </strong>In this multi-institutional database study using FSS scores to describe a contemporary, heterogeneous patient population with recurrent PICU-based observations of functional status, we identified six classes of outcome trajectories with different clinical and demographic characteristics.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":"99-107"},"PeriodicalIF":6.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12702461/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145494986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-10-17DOI: 10.1097/CCM.0000000000006899
Ville Pettilä, Carmen A Pfortmüller, Anders Perner, Tobias M Merz, Erika Wilkman, Johanna Hästbacka, Matthias F Lang, Paolo Lombardo, Tuomas Selander, Stephan M Jakob, Jukka Takala
Objectives: To determine whether treatment targeting improving tissue perfusion while allowing lower than recommended blood pressure (targeted tissue perfusion [TTP]) improves outcome compared with mean arterial pressure (MAP)-guided standard care (SC).
Design: A randomized, parallel-group, open-label clinical trial with 30-day follow-up. Allocation was stratified according to trial site and presence of chronic arterial hypertension.
Setting: Three European university hospital ICUs with enrollment from 2016 to 2022.
Patients: Two hundred nineteen patients with septic shock and blood lactate greater than 3 mmol/L allocated to TTP ( n = 111) vs. SC ( n = 108).
Interventions: The TTP protocol comprised capillary refill time, peripheral skin temperature, arterial lactate concentrations, and MAP 50-65 mm Hg. The SC protocol comprised the hemodynamic targets of 2012 Surviving Sepsis Campaign.
Measurements and main results: Ninety-seven (87.4%) in TTP and 97 (89.8%) in SC group (total n = 194) were analyzed for the primary outcome. The median (interquartile range) of days alive in 30 days with normal lactate and without vasopressor/inotropic drugs (primary outcome) was 23 (10-27) in TTP group and 22 (1-27) in SC group (difference in medians, 0.59; 95% CI, -3 to 4). Secondary outcomes (single components of the primary outcome, days alive without organ support and mortality, all at 30 d) and serious adverse reactions were not significantly different between intervention groups. At day 30, 24 patients (24.7%) in TTP group vs. 27 patients (27.8%) in SC group had died. MAP levels were lower in the TTP group vs. the SC group.
Conclusions: In ICU patients with septic shock and lactate greater than 3 mmol/L, targeting tissue perfusion and allowing lower than recommended MAP did not increase the number of days alive with normal lactate and without vasopressor/inotropic drugs at 30 days. No additional safety concerns with the TTP strategy were detected compared with SC.
{"title":"Targeted Tissue Perfusion Versus Macrocirculatory-Guided Standard Care in Patients With Septic Shock: A Randomized Clinical Trial-The TARTARE-2S Trial.","authors":"Ville Pettilä, Carmen A Pfortmüller, Anders Perner, Tobias M Merz, Erika Wilkman, Johanna Hästbacka, Matthias F Lang, Paolo Lombardo, Tuomas Selander, Stephan M Jakob, Jukka Takala","doi":"10.1097/CCM.0000000000006899","DOIUrl":"10.1097/CCM.0000000000006899","url":null,"abstract":"<p><strong>Objectives: </strong>To determine whether treatment targeting improving tissue perfusion while allowing lower than recommended blood pressure (targeted tissue perfusion [TTP]) improves outcome compared with mean arterial pressure (MAP)-guided standard care (SC).</p><p><strong>Design: </strong>A randomized, parallel-group, open-label clinical trial with 30-day follow-up. Allocation was stratified according to trial site and presence of chronic arterial hypertension.</p><p><strong>Setting: </strong>Three European university hospital ICUs with enrollment from 2016 to 2022.</p><p><strong>Patients: </strong>Two hundred nineteen patients with septic shock and blood lactate greater than 3 mmol/L allocated to TTP ( n = 111) vs. SC ( n = 108).</p><p><strong>Interventions: </strong>The TTP protocol comprised capillary refill time, peripheral skin temperature, arterial lactate concentrations, and MAP 50-65 mm Hg. The SC protocol comprised the hemodynamic targets of 2012 Surviving Sepsis Campaign.</p><p><strong>Measurements and main results: </strong>Ninety-seven (87.4%) in TTP and 97 (89.8%) in SC group (total n = 194) were analyzed for the primary outcome. The median (interquartile range) of days alive in 30 days with normal lactate and without vasopressor/inotropic drugs (primary outcome) was 23 (10-27) in TTP group and 22 (1-27) in SC group (difference in medians, 0.59; 95% CI, -3 to 4). Secondary outcomes (single components of the primary outcome, days alive without organ support and mortality, all at 30 d) and serious adverse reactions were not significantly different between intervention groups. At day 30, 24 patients (24.7%) in TTP group vs. 27 patients (27.8%) in SC group had died. MAP levels were lower in the TTP group vs. the SC group.</p><p><strong>Conclusions: </strong>In ICU patients with septic shock and lactate greater than 3 mmol/L, targeting tissue perfusion and allowing lower than recommended MAP did not increase the number of days alive with normal lactate and without vasopressor/inotropic drugs at 30 days. No additional safety concerns with the TTP strategy were detected compared with SC.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":"24-34"},"PeriodicalIF":6.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145307122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives: Acute kidney injury (AKI) occurs frequently in ICUs and is associated with poor outcomes. However, little is known about AKI in patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR) for out-of-hospital cardiac arrest (OHCA). Our aims were to identify real-world data on AKI in the early phase of intensive care, examine the relationship between AKI and outcomes, and identify factors contributing to the occurrence of AKI in patients undergoing ECPR for OHCA.
Design: A secondary analysis of the Study of Advanced life support for Ventricular fibrillation with Extracorporeal circulation in Japan (SAVE-J II study), a retrospective multicenter study involving patients 18 years old or older who experienced OHCA and received ECPR between 2013 and 2018.
Setting: Thirty-six ICUs that participated in the SAVE-J II study in Japan.
Patients: Adult patients with OHCA of presumed cardiac etiology who received ECPR and were admitted to the ICU.
Interventions: None.
Measurements and main results: In this study, AKI was defined based on the Kidney Disease: Improving Global Outcomes criteria with regard to serum creatinine level during the 4 days after ICU admission. The primary outcome was in-hospital mortality, and the secondary outcome was an unfavorable neurologic outcome (Cerebral Performance Category scores of 3-5 at discharge). Among the 943 patients, AKI occurred in 66.9% ( n = 631). Multivariable analysis showed that AKI was significantly associated with in-hospital mortality (odds ratio [OR], 4.15; 95% CI, 3.05-5.66; p < 0.001) and with unfavorable neurologic outcomes (OR, 3.43; 95% CI, 2.42-4.87; p < 0.001). Furthermore, age, time course, pH level at hospital arrival, creatinine level at hospital admission, and blood pressure on ICU admission were significantly associated with the occurrence of AKI.
Conclusions: This large cohort study revealed that AKI was commonly observed during the early phase after ECPR for OHCA and was associated with in-hospital mortality and unfavorable neurologic outcomes.
目的:急性肾损伤(AKI)在icu中经常发生,并与不良预后相关。然而,对于院外心脏骤停(OHCA)患者接受体外心肺复苏(ECPR)的AKI,我们所知甚少。我们的目的是确定重症监护早期AKI的真实数据,检查AKI与预后之间的关系,并确定导致OHCA患者接受ECPR发生AKI的因素。设计:对日本室性颤动体外循环晚期生命支持研究(SAVE-J II研究)的二次分析,这是一项回顾性多中心研究,涉及2013年至2018年期间经历OHCA并接受ECPR的18岁或以上患者。背景:日本参加SAVE-J II研究的36例icu患者。患者:推定为心脏病因的成年OHCA患者,接受ECPR并入住ICU。干预措施:没有。测量和主要结果:在本研究中,AKI的定义是基于肾脏疾病:改善全球结局标准,即ICU入院后4天内的血清肌酐水平。主要结局是住院死亡率,次要结局是不利的神经系统结局(出院时脑功能分类评分为3-5)。943例患者中,AKI发生率为66.9% (n = 631)。多变量分析显示,AKI与住院死亡率显著相关(比值比[OR], 4.15; 95% CI, 3.05-5.66; p < 0.001),与不良的神经系统预后显著相关(比值比[OR], 3.43; 95% CI, 2.42-4.87; p < 0.001)。此外,年龄、病程、入院时pH值、入院时肌酐水平和ICU入院时血压与AKI的发生显著相关。结论:这项大型队列研究显示,急性肾损伤在OHCA患者ECPR后的早期阶段很常见,并与住院死亡率和不利的神经系统预后相关。
{"title":"Acute Kidney Injury After Extracorporeal Cardiopulmonary Resuscitation for Out-of-Hospital Cardiac Arrest.","authors":"Takuya Taira, Akihiko Inoue, Shinichi Ijuin, Takeshi Nishimura, Taiki Moriyama, Masahide Omoda, Toru Hifumi, Tetsuya Sakamoto, Yasuhiro Kuroda, Satoshi Ishihara","doi":"10.1097/CCM.0000000000006946","DOIUrl":"10.1097/CCM.0000000000006946","url":null,"abstract":"<p><strong>Objectives: </strong>Acute kidney injury (AKI) occurs frequently in ICUs and is associated with poor outcomes. However, little is known about AKI in patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR) for out-of-hospital cardiac arrest (OHCA). Our aims were to identify real-world data on AKI in the early phase of intensive care, examine the relationship between AKI and outcomes, and identify factors contributing to the occurrence of AKI in patients undergoing ECPR for OHCA.</p><p><strong>Design: </strong>A secondary analysis of the Study of Advanced life support for Ventricular fibrillation with Extracorporeal circulation in Japan (SAVE-J II study), a retrospective multicenter study involving patients 18 years old or older who experienced OHCA and received ECPR between 2013 and 2018.</p><p><strong>Setting: </strong>Thirty-six ICUs that participated in the SAVE-J II study in Japan.</p><p><strong>Patients: </strong>Adult patients with OHCA of presumed cardiac etiology who received ECPR and were admitted to the ICU.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>In this study, AKI was defined based on the Kidney Disease: Improving Global Outcomes criteria with regard to serum creatinine level during the 4 days after ICU admission. The primary outcome was in-hospital mortality, and the secondary outcome was an unfavorable neurologic outcome (Cerebral Performance Category scores of 3-5 at discharge). Among the 943 patients, AKI occurred in 66.9% ( n = 631). Multivariable analysis showed that AKI was significantly associated with in-hospital mortality (odds ratio [OR], 4.15; 95% CI, 3.05-5.66; p < 0.001) and with unfavorable neurologic outcomes (OR, 3.43; 95% CI, 2.42-4.87; p < 0.001). Furthermore, age, time course, pH level at hospital arrival, creatinine level at hospital admission, and blood pressure on ICU admission were significantly associated with the occurrence of AKI.</p><p><strong>Conclusions: </strong>This large cohort study revealed that AKI was commonly observed during the early phase after ECPR for OHCA and was associated with in-hospital mortality and unfavorable neurologic outcomes.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":"87-98"},"PeriodicalIF":6.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145494889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives: While potential risks for limb ischemia have been explored in studies of venoarterial extracorporeal membrane oxygenation (ECMO), they remain inadequately defined for patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR). We identified risk factors for the development of lower limb ischemia during ECPR using a large nationwide ECPR cohort.
Design: A post hoc analysis was conducted using a nationwide, multicenter, retrospective study (Study of Advanced Cardiac Life Support for Ventricular Fibrillation with Extracorporeal Circulation in Japan II [SAVE-J II]).
Setting: Thirty-six institutions from 2013 to 2018.
Patients: Adult patients who underwent ECPR for out-of-hospital cardiac arrest.
Interventions: None.
Measurements and main results: Lower limb ischemia was defined as the requirement for a therapeutic distal perfusion catheter (DPC), fasciotomy, or amputation. Risk factors for lower limb ischemia were assessed using multivariate logistic regression models that included patient characteristics, ECPR-related information, and resuscitation content as potential confounders. Of the 969 patients, 72 (7.4%) developed lower limb ischemia. No significant differences were observed regarding background characteristics, cannulation location, puncture method, or venoarterial ECMO catheter size between patients with and without limb ischemia. However, a prophylactic DPC was less frequently employed in patients with lower limb ischemia than in those without (4 [5.6%] vs. 219 [24.4%]; p < 0.001). Higher incidences of cannulation-related bleeding and cannula malposition were observed in patients with limb ischemia than in those in patients without limb ischemia (22 [30.6%] vs. 162 [18.1%]; p = 0.009 and 9 [12.5%] vs. 29 [3.2%]; p < 0.001, respectively). Multivariable analyses revealed that prophylactic DPC placement was associated with a lower risk of limb ischemia (0.20 [0.07-0.55]; p = 0.002), whereas cannulation-related bleeding and cannula malposition were linked to an increased risk of lower limb ischemia (1.83 [1.06-3.14]; p = 0.030 and 3.81 [1.68-8.64]; p = 0.001, respectively).
Conclusions: Lower limb ischemia during ECPR would be anticipated in patients with cannulation-related complications, and prophylactic DPC placement may be considered to mitigate the risk of lower limb ischemia.
{"title":"Risk of Developing Lower Limb Ischemia in Patients With Extracorporeal Cardiopulmonary Resuscitation: A Secondary Analysis of the Study of Advanced Cardiac Life Support for Ventricular Fibrillation With Extracorporeal Circulation in Japan II (SAVE-J II) Study.","authors":"Kazuki Matsumura, Ryo Yamamoto, Daiki Kaito, Koichiro Homma, Akihiko Inoue, Toru Hifumi, Tetsuya Sakamoto, Yasuhiro Kuroda, Junichi Sasaki","doi":"10.1097/CCM.0000000000007010","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007010","url":null,"abstract":"<p><strong>Objectives: </strong>While potential risks for limb ischemia have been explored in studies of venoarterial extracorporeal membrane oxygenation (ECMO), they remain inadequately defined for patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR). We identified risk factors for the development of lower limb ischemia during ECPR using a large nationwide ECPR cohort.</p><p><strong>Design: </strong>A post hoc analysis was conducted using a nationwide, multicenter, retrospective study (Study of Advanced Cardiac Life Support for Ventricular Fibrillation with Extracorporeal Circulation in Japan II [SAVE-J II]).</p><p><strong>Setting: </strong>Thirty-six institutions from 2013 to 2018.</p><p><strong>Patients: </strong>Adult patients who underwent ECPR for out-of-hospital cardiac arrest.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>Lower limb ischemia was defined as the requirement for a therapeutic distal perfusion catheter (DPC), fasciotomy, or amputation. Risk factors for lower limb ischemia were assessed using multivariate logistic regression models that included patient characteristics, ECPR-related information, and resuscitation content as potential confounders. Of the 969 patients, 72 (7.4%) developed lower limb ischemia. No significant differences were observed regarding background characteristics, cannulation location, puncture method, or venoarterial ECMO catheter size between patients with and without limb ischemia. However, a prophylactic DPC was less frequently employed in patients with lower limb ischemia than in those without (4 [5.6%] vs. 219 [24.4%]; p < 0.001). Higher incidences of cannulation-related bleeding and cannula malposition were observed in patients with limb ischemia than in those in patients without limb ischemia (22 [30.6%] vs. 162 [18.1%]; p = 0.009 and 9 [12.5%] vs. 29 [3.2%]; p < 0.001, respectively). Multivariable analyses revealed that prophylactic DPC placement was associated with a lower risk of limb ischemia (0.20 [0.07-0.55]; p = 0.002), whereas cannulation-related bleeding and cannula malposition were linked to an increased risk of lower limb ischemia (1.83 [1.06-3.14]; p = 0.030 and 3.81 [1.68-8.64]; p = 0.001, respectively).</p><p><strong>Conclusions: </strong>Lower limb ischemia during ECPR would be anticipated in patients with cannulation-related complications, and prophylactic DPC placement may be considered to mitigate the risk of lower limb ischemia.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145854829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-30DOI: 10.1097/CCM.0000000000007007
Chad H Hochberg, Anna K Barker, Alhareth Alsagban, Sophia Emetu, Bhavna Seth, Olive Tang, Shavin Thomas, Kevin J Psoter, Michelle N Eakin, Michael W Sjoding, Theodore J Iwashyna, David N Hager
Objectives: To characterize the performance of an electronic health record (EHR) data-based classifier of persistent moderate-to-severe acute respiratory distress syndrome (ARDS).
Design: Retrospective observational study.
Setting: Six ICUs from two health systems.
Patients: We included adults receiving greater than or equal to 24 hours of invasive mechanical ventilation (IMV) with a Pao2/Fio2 of less than or equal to 150 mm Hg on Fio2 greater than or equal to 0.6 in the first 72 hours of IMV. We evaluated classifier performance in two temporally and geographically distinct cohorts: a development cohort including patients in one of two academic medical or three mixed community ICUs in the first 3 months of 2021 or in 2022-2023, and a validation cohort from a different academic medical ICU in 2017.
Interventions: None.
Measurements and main results: In both cohorts, study physicians assessed patients for clinical ARDS criteria. We retrospectively applied the EHR classifier, which required a persistent Pao2/Fio2 of less than or equal to 150 mm Hg or receipt of interventions to address severe hypoxemia (i.e., prone positioning, neuromuscular blockade, inhaled pulmonary vasodilators) in the 24 hours after initially meeting hypoxemia criteria. We also evaluated classifier definitions that used peripheral oxygen saturation (Spo2)/Fio2 of less than or equal to 162 to indicate persistent hypoxemia. Of 924 patients in the development cohort, 504 (55%) had clinician-adjudicated ARDS. Of 90 patients in the validation cohort, 48 (53%) had clinician-adjudicated ARDS. In the development and validation cohorts, the primary EHR-based classifier identified 382 and 38 patients as having persistent moderate-to-severe ARDS, respectively (positive predictive value [PPV], 71%; 95% CI, 66-75% and PPV, 66%; 95% CI, 50-81%). When Spo2/Fio2 was used as the second hypoxemia marker more patients were classified as ARDS in both development and validation cohorts but with lower PPVs (67% and 62%, respectively.).
Conclusions: An EHR-based classifier using readily available data had acceptable performance for identifying patients with persistent moderate-severe ARDS. This open-source tool could be used for retrospective or prospective identification of this vulnerable population for research and quality improvement initiatives.
目的:描述基于电子健康记录(EHR)数据的持续中重度急性呼吸窘迫综合征(ARDS)分类器的性能。设计:回顾性观察性研究。环境:来自两个卫生系统的6个icu。患者:我们纳入了接受大于或等于24小时有创机械通气(IMV)的成人,在IMV的前72小时内,Pao2/Fio2小于或等于150 mm Hg, Fio2大于或等于0.6。我们在两个时间和地理上不同的队列中评估了分类器的性能:一个是发展队列,包括2021年前3个月或2022-2023年两个学术医学ICU或三个混合社区ICU中的一个患者,另一个是2017年来自不同学术医学ICU的验证队列。干预措施:没有。测量和主要结果:在两个队列中,研究医生评估了患者的临床ARDS标准。我们回顾性地应用了EHR分类,该分类要求在最初满足低氧血症标准后24小时内持续Pao2/Fio2小于或等于150 mm Hg或接受干预以解决严重低氧血症(即俯卧位,神经肌肉阻断,吸入肺血管扩张剂)。我们还评估了使用外周氧饱和度(Spo2)/Fio2小于或等于162来指示持续低氧血症的分类器定义。在发展队列的924例患者中,504例(55%)患有临床判定的ARDS。在验证队列的90例患者中,48例(53%)患有临床判定的ARDS。在开发和验证队列中,基于ehr的主要分类器分别鉴定出382例和38例患者患有持续性中至重度ARDS(阳性预测值[PPV], 71%; 95% CI, 66-75%; PPV, 66%; 95% CI, 50-81%)。当Spo2/Fio2作为第二个低氧血症标志物时,在开发和验证队列中,更多的患者被归类为ARDS,但ppv较低(分别为67%和62%)。结论:基于ehr的分类器使用现成的数据识别持续性中重度ARDS患者具有可接受的性能。这个开源工具可以用于回顾性或前瞻性地识别这一弱势群体,以进行研究和质量改进活动。
{"title":"An Electronic Health Record-Based Classifier for Moderate-to-Severe Acute Respiratory Distress Syndrome With Persistent Hypoxemia.","authors":"Chad H Hochberg, Anna K Barker, Alhareth Alsagban, Sophia Emetu, Bhavna Seth, Olive Tang, Shavin Thomas, Kevin J Psoter, Michelle N Eakin, Michael W Sjoding, Theodore J Iwashyna, David N Hager","doi":"10.1097/CCM.0000000000007007","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007007","url":null,"abstract":"<p><strong>Objectives: </strong>To characterize the performance of an electronic health record (EHR) data-based classifier of persistent moderate-to-severe acute respiratory distress syndrome (ARDS).</p><p><strong>Design: </strong>Retrospective observational study.</p><p><strong>Setting: </strong>Six ICUs from two health systems.</p><p><strong>Patients: </strong>We included adults receiving greater than or equal to 24 hours of invasive mechanical ventilation (IMV) with a Pao2/Fio2 of less than or equal to 150 mm Hg on Fio2 greater than or equal to 0.6 in the first 72 hours of IMV. We evaluated classifier performance in two temporally and geographically distinct cohorts: a development cohort including patients in one of two academic medical or three mixed community ICUs in the first 3 months of 2021 or in 2022-2023, and a validation cohort from a different academic medical ICU in 2017.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>In both cohorts, study physicians assessed patients for clinical ARDS criteria. We retrospectively applied the EHR classifier, which required a persistent Pao2/Fio2 of less than or equal to 150 mm Hg or receipt of interventions to address severe hypoxemia (i.e., prone positioning, neuromuscular blockade, inhaled pulmonary vasodilators) in the 24 hours after initially meeting hypoxemia criteria. We also evaluated classifier definitions that used peripheral oxygen saturation (Spo2)/Fio2 of less than or equal to 162 to indicate persistent hypoxemia. Of 924 patients in the development cohort, 504 (55%) had clinician-adjudicated ARDS. Of 90 patients in the validation cohort, 48 (53%) had clinician-adjudicated ARDS. In the development and validation cohorts, the primary EHR-based classifier identified 382 and 38 patients as having persistent moderate-to-severe ARDS, respectively (positive predictive value [PPV], 71%; 95% CI, 66-75% and PPV, 66%; 95% CI, 50-81%). When Spo2/Fio2 was used as the second hypoxemia marker more patients were classified as ARDS in both development and validation cohorts but with lower PPVs (67% and 62%, respectively.).</p><p><strong>Conclusions: </strong>An EHR-based classifier using readily available data had acceptable performance for identifying patients with persistent moderate-severe ARDS. This open-source tool could be used for retrospective or prospective identification of this vulnerable population for research and quality improvement initiatives.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145854796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-30DOI: 10.1097/CCM.0000000000007000
Prabalini Rajendram, R Scott Stephens, Anne Rain T Brown, Heather P May, Joseph L Nates, Stephen M Pastores, Ananda Dharshan, Alice Gallo de Moraes, Matthew K Hensley, Lei Feng, Colleen McEvoy, Sikemi Ibikunle, Melissa Beasley, Elena Mead, Jason Westin, Natalie T Kostelecky, Simon Mucha, Agrima Mian, Sairah Ahmed, Arsal Tharwani, Brian T Hill, Megan M Herr, Yi Lin, Cristina Gutierrez
Objectives: To evaluate evolving management, ICU admission, and outcomes for critically ill chimeric antigen receptor (CAR) T-cell patients over a 6-year period.
Design: Multicenter retrospective cohort study from January 2018 to September 2023.
Setting: Eight U.S. centers.
Patients: Adult CAR T-cell patients requiring ICU admission.
Interventions: None.
Methods: Summary statistics included mean, sd, median, and interquartile range (IQR). Fisher exact test or chi-square test were used to evaluate association between year treated and other categorical variables. Cochran-Armitage test was performed to assess significance of trends across years. Multivariable logistic regression was performed to assess covariates associated with mortality.
Measurements and main results: Demographics, toxicity management, ICU admission, support modalities, toxicity severity, and survival (ICU, hospital, and 3-mo) were compared year-to-year. From 2018 to 2023, 2238 patients received CAR T cells, with increasing number of patients treated yearly; 398 (17.8%) required ICU care. Of those admitted to the ICU, 66.1% were male, 89.2% had lymphoma, and median age was 64 years (53-71 yr). ICU admission rates declined from 38.5% (95% CI, 31.6-45.8%) in 2018 to 16.4% in 2023 (95% CI, 13.5-19.7%; p < 0.0001). Cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome was the reason for ICU admission in 87.9%. In 2023 vs. 2018, ICU patients were older (median, 65 yr [IQR, 55-73 yr] vs. 58 yr [48-67 yr]; p = 0.003) with higher comorbidity indices (4 [4-6] vs. 3 [2-4]; p = 0.005) and more severe toxicities (≥ grade 3: 90.1% vs. 69.9%; p = 0.004). Corticosteroid use for less severe toxicities (≤ grade 2 toxicity: 73.8% vs. 40.6%; p = 0.0001) and anakinra use (56% vs. 5.5%; p < 0.0001) increased throughout the years. Mortality from cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome remained low (5.5%). Age, Sequential Organ Failure Assessment greater than or equal to 10 at ICU admission, and ICU admission for noncytokine release/neurotoxicity syndrome reasons were associated with hospital mortality (odds ratios, 1.02 [95% CI, 1-1.04; p = 0.046], 4.69 [2.44-9.01; p < 0.0001], and 3.74 [1.91-7.3; p = 0.0001], respectively).
Conclusions: ICU admission rates after CAR T-cell treatment are declining. Although ICU patients are older with higher severity of illness and toxicity grades, ICU mortality after CAR T-cell therapy remains low.
目的:评估6年来CAR - t细胞危重患者的管理、ICU入院和预后。设计:2018年1月至2023年9月的多中心回顾性队列研究。地点:美国8个中心。患者:需要ICU住院的成人CAR - t细胞患者。干预措施:没有。方法:汇总统计包括平均值、标准差、中位数和四分位差(IQR)。采用Fisher精确检验或卡方检验评价治疗年份与其他分类变量的相关性。采用Cochran-Armitage检验评估各年趋势的显著性。采用多变量逻辑回归评估与死亡率相关的协变量。测量和主要结果:人口统计学、毒性管理、ICU入院、支持方式、毒性严重程度和生存率(ICU、医院和3个月)逐年比较。从2018年到2023年,有2238例患者接受了CAR - T细胞治疗,每年接受治疗的患者数量都在增加;398例(17.8%)需要ICU护理。入住ICU的患者中,66.1%为男性,89.2%为淋巴瘤,中位年龄为64岁(53-71岁)。ICU住院率从2018年的38.5% (95% CI, 31.6-45.8%)下降到2023年的16.4% (95% CI, 13.5-19.7%; p < 0.0001)。87.9%的患者因细胞因子释放综合征或免疫效应细胞相关神经毒性综合征入院。2023年与2018年相比,ICU患者年龄更大(中位数为65岁[IQR, 55-73岁]对58岁[48-67岁],p = 0.003),合并症指数更高(4[4-6]对3 [2-4],p = 0.005),毒性更严重(≥3级:90.1%对69.9%,p = 0.004)。皮质类固醇用于较轻毒性(≤2级毒性:73.8% vs. 40.6%; p = 0.0001)和阿那白拉的使用逐年增加(56% vs. 5.5%; p < 0.0001)。细胞因子释放综合征和免疫效应细胞相关神经毒性综合征的死亡率仍然很低(5.5%)。年龄、ICU入院时序期器官衰竭评分大于或等于10分、非细胞因子释放/神经毒性综合征原因入院与住院死亡率相关(比值比分别为1.02 [95% CI, 1-1.04; p = 0.046]、4.69 [2.44-9.01;p < 0.0001]、3.74 [1.91-7.3;p = 0.0001])。结论:CAR - t细胞治疗后ICU住院率呈下降趋势。尽管ICU患者年龄较大,病情严重程度和毒性等级较高,但CAR - t细胞治疗后的ICU死亡率仍然很低。
{"title":"Six-Year Trends in ICU Admission, Management, and Outcomes of Chimeric Antigen Receptor T-Cell Patients in the ICU.","authors":"Prabalini Rajendram, R Scott Stephens, Anne Rain T Brown, Heather P May, Joseph L Nates, Stephen M Pastores, Ananda Dharshan, Alice Gallo de Moraes, Matthew K Hensley, Lei Feng, Colleen McEvoy, Sikemi Ibikunle, Melissa Beasley, Elena Mead, Jason Westin, Natalie T Kostelecky, Simon Mucha, Agrima Mian, Sairah Ahmed, Arsal Tharwani, Brian T Hill, Megan M Herr, Yi Lin, Cristina Gutierrez","doi":"10.1097/CCM.0000000000007000","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007000","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate evolving management, ICU admission, and outcomes for critically ill chimeric antigen receptor (CAR) T-cell patients over a 6-year period.</p><p><strong>Design: </strong>Multicenter retrospective cohort study from January 2018 to September 2023.</p><p><strong>Setting: </strong>Eight U.S. centers.</p><p><strong>Patients: </strong>Adult CAR T-cell patients requiring ICU admission.</p><p><strong>Interventions: </strong>None.</p><p><strong>Methods: </strong>Summary statistics included mean, sd, median, and interquartile range (IQR). Fisher exact test or chi-square test were used to evaluate association between year treated and other categorical variables. Cochran-Armitage test was performed to assess significance of trends across years. Multivariable logistic regression was performed to assess covariates associated with mortality.</p><p><strong>Measurements and main results: </strong>Demographics, toxicity management, ICU admission, support modalities, toxicity severity, and survival (ICU, hospital, and 3-mo) were compared year-to-year. From 2018 to 2023, 2238 patients received CAR T cells, with increasing number of patients treated yearly; 398 (17.8%) required ICU care. Of those admitted to the ICU, 66.1% were male, 89.2% had lymphoma, and median age was 64 years (53-71 yr). ICU admission rates declined from 38.5% (95% CI, 31.6-45.8%) in 2018 to 16.4% in 2023 (95% CI, 13.5-19.7%; p < 0.0001). Cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome was the reason for ICU admission in 87.9%. In 2023 vs. 2018, ICU patients were older (median, 65 yr [IQR, 55-73 yr] vs. 58 yr [48-67 yr]; p = 0.003) with higher comorbidity indices (4 [4-6] vs. 3 [2-4]; p = 0.005) and more severe toxicities (≥ grade 3: 90.1% vs. 69.9%; p = 0.004). Corticosteroid use for less severe toxicities (≤ grade 2 toxicity: 73.8% vs. 40.6%; p = 0.0001) and anakinra use (56% vs. 5.5%; p < 0.0001) increased throughout the years. Mortality from cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome remained low (5.5%). Age, Sequential Organ Failure Assessment greater than or equal to 10 at ICU admission, and ICU admission for noncytokine release/neurotoxicity syndrome reasons were associated with hospital mortality (odds ratios, 1.02 [95% CI, 1-1.04; p = 0.046], 4.69 [2.44-9.01; p < 0.0001], and 3.74 [1.91-7.3; p = 0.0001], respectively).</p><p><strong>Conclusions: </strong>ICU admission rates after CAR T-cell treatment are declining. Although ICU patients are older with higher severity of illness and toxicity grades, ICU mortality after CAR T-cell therapy remains low.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145854827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-29DOI: 10.1097/CCM.0000000000007012
Thomas Langer
{"title":"Monitoring Respiratory Effort During High-Flow Nasal Cannula Therapy: Any Role for Diaphragmatic Ultrasound?","authors":"Thomas Langer","doi":"10.1097/CCM.0000000000007012","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007012","url":null,"abstract":"","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145849049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-29DOI: 10.1097/CCM.0000000000007004
HyunBin You, Wei Pan, Deepshikha C Ashana, Sharron L Docherty, Christopher E Cox, Tolu O Oyesanya
Objectives: To examine how accurately ICU clinicians perceived family-reported prognostic expectations (FPEs) for patients with prolonged mechanical ventilation (PMV).
Design: A cross-sectional, exploratory design using secondary analysis.
Setting: Thirteen ICUs across five hospitals in the United States.
Subjects: Family members of patients with PMV and ICU clinicians, including physicians and nurses.
Interventions: None.
Measurements and main results: Latent profile analysis was used to identify profiles of accuracy in clinician perception of FPE, followed by bivariate analyses and multinomial logistic regression to examine associations between patient, family, and clinician characteristics and profile membership. A total of 554 participants (239 family members, 150 physicians, and 165 nurses) were included. Five distinct latent profiles of accuracy in clinician perception of FPE were identified: 1) clinician underestimation of FPE; 2) clinician overestimation of FPE; 3) accurate perception: low prognosis; 4) accurate perception: moderate prognosis; and 5) accurate perception: high prognosis. Families in profile 1 (clinician underestimation of FPE) were more likely to be spouses/partners of patients and reported higher levels of hope and optimism, whereas those in profile 2 (clinician overestimation of FPE) reported lower levels. Patient characteristics, including age, employment status, admission to medical ICU, and pulmonary-related hospital diagnosis, were statistically significantly associated with the profile membership.
Conclusions: Understanding how accurately clinicians perceive FPE is vital to improving shared decision-making and developing goal-concordant care for patients with PMV. Further research examining strategies for clinicians to accurately perceive what families believe about prognosis is needed to identify potential misalignment, initiate timely and empathetic conversations, and build toward shared decision-making and goal-concordant care.
{"title":"Are We on the Same Page? Clinician Perceptions of Family Prognostic Expectations for Critically Ill Patients.","authors":"HyunBin You, Wei Pan, Deepshikha C Ashana, Sharron L Docherty, Christopher E Cox, Tolu O Oyesanya","doi":"10.1097/CCM.0000000000007004","DOIUrl":"10.1097/CCM.0000000000007004","url":null,"abstract":"<p><strong>Objectives: </strong>To examine how accurately ICU clinicians perceived family-reported prognostic expectations (FPEs) for patients with prolonged mechanical ventilation (PMV).</p><p><strong>Design: </strong>A cross-sectional, exploratory design using secondary analysis.</p><p><strong>Setting: </strong>Thirteen ICUs across five hospitals in the United States.</p><p><strong>Subjects: </strong>Family members of patients with PMV and ICU clinicians, including physicians and nurses.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>Latent profile analysis was used to identify profiles of accuracy in clinician perception of FPE, followed by bivariate analyses and multinomial logistic regression to examine associations between patient, family, and clinician characteristics and profile membership. A total of 554 participants (239 family members, 150 physicians, and 165 nurses) were included. Five distinct latent profiles of accuracy in clinician perception of FPE were identified: 1) clinician underestimation of FPE; 2) clinician overestimation of FPE; 3) accurate perception: low prognosis; 4) accurate perception: moderate prognosis; and 5) accurate perception: high prognosis. Families in profile 1 (clinician underestimation of FPE) were more likely to be spouses/partners of patients and reported higher levels of hope and optimism, whereas those in profile 2 (clinician overestimation of FPE) reported lower levels. Patient characteristics, including age, employment status, admission to medical ICU, and pulmonary-related hospital diagnosis, were statistically significantly associated with the profile membership.</p><p><strong>Conclusions: </strong>Understanding how accurately clinicians perceive FPE is vital to improving shared decision-making and developing goal-concordant care for patients with PMV. Further research examining strategies for clinicians to accurately perceive what families believe about prognosis is needed to identify potential misalignment, initiate timely and empathetic conversations, and build toward shared decision-making and goal-concordant care.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12766653/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145849119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-23DOI: 10.1097/CCM.0000000000006995
Marianne E Nellis, Bradley J Barney, Garrett Coles, Jill M Cholette, Tarif A Choudhury, Jamie Furlong-Dillard, Caroline Ozment, Jesse Bain, Robert A Niebler, Madhuradhar Chegondi, Aditya Badheka, Ofer Schiller, Eran Shostak, Umesh Joashi, Matthew Paden, Jessica S Alvey, Jennifer A Muszynski, Philip C Spinella, Marisa Tucci, Jacques Lacroix, Simon Stanworth, Erika R O'Neil, Uri Pollak, Timothy Bahr, S Ram Kumar, Oliver Karam
Objectives: To evaluate the feasibility of randomizing children on extracorporeal membrane oxygenation (ECMO) to one of two prophylactic platelet transfusion thresholds.
Design: Randomized controlled trial.
Setting: Ten ECMO centers (nine in United States, one in Israel).
Patients: Critically ill children (0 to younger than 18 yr), supported on ECMO, with no or minimal bleeding within 24 hours of cannulation.
Interventions: Children were randomized to a higher platelet threshold (transfused when platelet count < 90 × 109/L) or a lower platelet threshold (transfused when platelet count < 50 × 109/L). Primary feasibility outcome was pre-transfusion platelet count to test for a difference between strategies. Primary safety outcome was progression to severe bleeding, severe clotting, and/or all-cause mortality.
Measurements and main results: Of 159 patients screened for eligibility, 77% (123/159) met eligibility criteria. Sixty-five percent (80/123) of caregivers were approached for consent. Consent was obtained in 63% (50/80). Enrolled children had a median age of 0.2 years (interquartile range 0.0; 1.7) and 88% (44/50) were supported by veno-arterial (V-A) ECMO. The model-adjusted mean difference in pre-transfusion platelet count between the groups was 32 × 109/L (p < 0.001). Compliance with assigned transfusion threshold was 99.2%. Eleven (22%) children experienced the primary safety outcome. Progression to severe bleeding occurred in 14% (7/50) of patients, whereas progression to severe clotting was observed in 4% (2/50).
Conclusions: Non-bleeding children on ECMO can be screened, enrolled and randomized to different platelet transfusion strategies within 24 hours of cannulation. Compliance with the protocol was excellent with significant separation in pre-transfusion platelet counts between the arms. Severe bleeding and severe clotting occurred at similar rates in both thresholds. A larger, definitive trial is feasible and needed.
{"title":"Platelet Transfusion Thresholds for Children Supported by Extracorporeal Membrane Oxygenation: The Extracorporeal Membrane Oxygenation Hemostatic Transfusions in Children (ECSTATIC) Feasibility Clinical Trial.","authors":"Marianne E Nellis, Bradley J Barney, Garrett Coles, Jill M Cholette, Tarif A Choudhury, Jamie Furlong-Dillard, Caroline Ozment, Jesse Bain, Robert A Niebler, Madhuradhar Chegondi, Aditya Badheka, Ofer Schiller, Eran Shostak, Umesh Joashi, Matthew Paden, Jessica S Alvey, Jennifer A Muszynski, Philip C Spinella, Marisa Tucci, Jacques Lacroix, Simon Stanworth, Erika R O'Neil, Uri Pollak, Timothy Bahr, S Ram Kumar, Oliver Karam","doi":"10.1097/CCM.0000000000006995","DOIUrl":"https://doi.org/10.1097/CCM.0000000000006995","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the feasibility of randomizing children on extracorporeal membrane oxygenation (ECMO) to one of two prophylactic platelet transfusion thresholds.</p><p><strong>Design: </strong>Randomized controlled trial.</p><p><strong>Setting: </strong>Ten ECMO centers (nine in United States, one in Israel).</p><p><strong>Patients: </strong>Critically ill children (0 to younger than 18 yr), supported on ECMO, with no or minimal bleeding within 24 hours of cannulation.</p><p><strong>Interventions: </strong>Children were randomized to a higher platelet threshold (transfused when platelet count < 90 × 109/L) or a lower platelet threshold (transfused when platelet count < 50 × 109/L). Primary feasibility outcome was pre-transfusion platelet count to test for a difference between strategies. Primary safety outcome was progression to severe bleeding, severe clotting, and/or all-cause mortality.</p><p><strong>Measurements and main results: </strong>Of 159 patients screened for eligibility, 77% (123/159) met eligibility criteria. Sixty-five percent (80/123) of caregivers were approached for consent. Consent was obtained in 63% (50/80). Enrolled children had a median age of 0.2 years (interquartile range 0.0; 1.7) and 88% (44/50) were supported by veno-arterial (V-A) ECMO. The model-adjusted mean difference in pre-transfusion platelet count between the groups was 32 × 109/L (p < 0.001). Compliance with assigned transfusion threshold was 99.2%. Eleven (22%) children experienced the primary safety outcome. Progression to severe bleeding occurred in 14% (7/50) of patients, whereas progression to severe clotting was observed in 4% (2/50).</p><p><strong>Conclusions: </strong>Non-bleeding children on ECMO can be screened, enrolled and randomized to different platelet transfusion strategies within 24 hours of cannulation. Compliance with the protocol was excellent with significant separation in pre-transfusion platelet counts between the arms. Severe bleeding and severe clotting occurred at similar rates in both thresholds. A larger, definitive trial is feasible and needed.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145809926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-19DOI: 10.1097/CCM.0000000000006983
Dominique Piquette, Christie Lee
{"title":"Designing Critical Care Training for Real-World Practice: Capturing Complexity in a Meaningful and Useful Way.","authors":"Dominique Piquette, Christie Lee","doi":"10.1097/CCM.0000000000006983","DOIUrl":"https://doi.org/10.1097/CCM.0000000000006983","url":null,"abstract":"","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145793411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}