CHEST critical care最新文献_第5页

Skeletal Muscle Is a Vital Organ During Critical Illness 骨骼肌是危重疾病时的重要器官

CHEST critical care

Pub Date : 2025-06-19 DOI: 10.1016/j.chstcc.2025.100187

Ariel Jaitovich MD, ATSF

引用次数: 0

Semiawake Extubation Semiawake拔管

CHEST critical care

Pub Date : 2025-06-09 DOI: 10.1016/j.chstcc.2025.100182

Flavia Gabe Beltrami MD, PhD , Felippe Leopoldo Dexheimer Neto MD, PhD

引用次数: 0

Surrogate Decision-Making Support Trials in the ICU ICU的替代决策支持试验

CHEST critical care

Pub Date : 2025-06-09 DOI: 10.1016/j.chstcc.2025.100183

Natalie A. Pattison DNSc, RN

引用次数: 0

Epidemiologic Characteristics and Management of Sepsis Among Previously Healthy Patients 先前健康患者败血症的流行病学特征和处理

CHEST critical care

Pub Date : 2025-06-01 DOI: 10.1016/j.chstcc.2025.100148

Rachel K. Hechtman MD , Megan E. Heath PhD , Jennifer K. Horowitz MA , Elizabeth McLaughlin MS, RN , Patricia J. Posa RN, BSN, MSA, CCRN , John Blamoun MD , Paul Bozyk MD , Megan Cahill DO, MBA, FACOEP , Rania Esteitie MD, FCCP, ATSF , Kevin Furlong DO , Namita Jayaprakash MB, BcH BAO, MRCEM , Jessica Jones PharmD , Maximiliano Tamae-Kakazu MD , Joan Nagelkirk MD , Thomas Pfotenhauer DO , Derek C. Angus MD, MPH, FRCP , Scott A. Flanders MD , Elizabeth S. Munroe MD , Hallie C. Prescott MD

Background

Most deaths resulting from sepsis occur among patients with advanced age, multiple morbidities, or frailty. It is unclear how many sepsis-related deaths truly are preventable. Previously healthy patients may provide insight into preventable sepsis mortality.

Research Question

What are the baseline characteristics, management, and outcomes associated with previously healthy patients with sepsis?

Study Design and Methods

This was a retrospective cohort of patients hospitalized for community-onset sepsis at 66 Michigan hospitals (November 2020-January 2024). We developed major and minor criteria to classify patients as previously healthy vs having significant comorbidities. We compared baseline characteristics, management, and outcomes of previously healthy patients vs patients with comorbid sepsis. Physicians reviewed charts of previously healthy patients with in-hospital death to evaluate baseline health status and rate preventability of death.

Results

Of 29,688 patients hospitalized for sepsis, 2,963 patients (10.0%) were classified as previously healthy. Previously healthy patients had median age of 53 years, a median of 2 minor comorbidities, and lower in-hospital mortality (5.8% vs 12.7%; P < .01) vs comorbid patients. Delivery of guideline-recommended early sepsis management ranged from 56.8% to 80.9% across individual care practices. Several care practices were less common among previously healthy patients, including lactate measurement (67.5% vs 73.8%; P < .01) and timely antibiotic administration (58.0% vs 66.3%; P < .01), whereas some were more common, including ≥ 30 mL/kg fluid resuscitation (72.4% vs 55.3%; P < .01). Among 48 charts of previously healthy decedents reviewed, 77.1% of patients were deemed to have life expectancy > 5 years without sepsis. Most deaths were judged to be unpreventable because of severity of illness on presentation.

Interpretation

We found that 1 in 10 patients with community-onset sepsis was healthy previously. Although gaps in in-hospital management were identified, deaths among previously healthy patients generally were deemed unpreventable with better in-hospital management because of patients seeking treatment too late in the course of sepsis. This study highlights system-level opportunities for better recognition and triage of sepsis before hospitalization.

背景：大多数败血症导致的死亡发生在高龄、多重发病或虚弱的患者中。目前尚不清楚有多少败血症相关的死亡是真正可以预防的。以前健康的患者可能提供可预防的败血症死亡率的见解。研究问题：先前健康的败血症患者的基线特征、管理和结局是什么？研究设计和方法：这是一项回顾性队列研究，纳入了2020年11月至2024年1月期间在密歇根州66家医院因社区发病败血症住院的患者。我们制定了主要和次要标准，将患者分为以前健康的和有显著合并症的。我们比较了既往健康患者与合并败血症患者的基线特征、管理和结局。医生回顾了先前健康的住院死亡患者的图表，以评估基线健康状况和死亡率的可预防性。结果29688例败血症住院患者中，2963例（10.0%）既往健康。既往健康患者的中位年龄为53岁，中位有2个轻微合并症，住院死亡率较低(5.8% vs 12.7%；P & lt;.01) vs合并症患者。在个人护理实践中，指南推荐的早期败血症管理的交付率从56.8%到80.9%不等。一些护理措施在以前健康的患者中不太常见，包括乳酸测量(67.5% vs 73.8%；P & lt;.01)和及时给药(58.0% vs 66.3%；P & lt;.01)，而有些更为常见，包括≥30 mL/kg液体复苏(72.4% vs 55.3%；P & lt;. 01)。在48个先前健康的死者的图表中，77.1%的患者被认为有预期寿命>；5年无脓毒症。由于病情严重，大多数死亡被认为是不可预防的。我们发现，1 / 10的社区性败血症患者以前是健康的。虽然发现了院内管理方面的差距，但由于患者在败血症过程中寻求治疗太晚，先前健康患者的死亡通常被认为是无法通过更好的院内管理来预防的。这项研究强调了在住院前更好地识别和分类败血症的系统级机会。

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引用次数: 0

Accuracy of Ultrasonography in Confirming Correct Positioning of Nasogastric Tube in the Intensive Care Setting 超声在重症监护中确定鼻胃管正确位置的准确性

CHEST critical care

Pub Date : 2025-05-29 DOI: 10.1016/j.chstcc.2025.100181

Alessandro F. Chiesa MD , Giulia Nenna MD , Christian Nicole , Francesco Caronni MD , Michael Llamas MD , Elisa Racina MD , Marco Previsdomini MD , Andrea Garbagnati MD , Alberto Pagnamenta MD

Background

Nasogastric tubes (NGTs) are used frequently in ICUs. Radiographic confirmation of correct placement represents the best available standard. According to a recently published Cochrane systematic review, ultrasonography has insufficient accuracy as a single test to confirm the correct placement.

Research Question

In a 2-step approach, is ultrasonography with a dynamic fogging test at the epigastric level reliable to confirm correct NGT placement?

Study Design and Methods

The study was conducted at 4 ICUs in Switzerland. The ultrasonography consisted of 2 parts: neck scan and epigastric scan with injection test. For safety concerns, only patients with a visible NGT in the esophagus underwent epigastric imaging with an injection test. We considered 3 results for the injection test: correct placement, incorrect placement, or uncertain placement in the stomach. Comparisons between the diagnostic test and the reference standard permitted to assess sensitivity, specificity, positive predictive value, negative predictive value, and accuracy.

Results

One hundred eighty-two patients were eligible for the study. The mean age was 68 years, 122 patients were male, 42 patients had obesity, and 120 patients were mechanically ventilated. Ten patients had to be excluded from the final analysis because of protocol violation or failed visualization of NGT in the esophagus. Dynamic fogging detection results were positive, negative, and inconclusive in 125 patients (73%), 39 patients (22%), and 8 patients (5%), respectively. Excluding inconclusive results, the test showed sensitivity of 79% (95% CI, 71.4%-84.7%), specificity of 100% (95% CI, 47.8%-100%), positive predictive value of 100% (95% CI, 97.1%-100%), negative predictive value of 13% (95% CI, 4.3%-27.4%), and an accuracy of 79.3% (95% CI, 72.3%-85.2%). Considering inconclusive results as both positive and negative, we obtained similar diagnostic test performances.

Interpretation

Our results indicate that in the ICU setting, the dynamic fogging test is a reliable method to confirm NGT placement in the stomach. It could reduce the need for radiography in a considerable number of patients.

Clinical Trial Registration

ClinicalTrials.gov; No.: NCT06693219; URL: www.clinicaltrials.gov

背景：鼻胃管（NGTs）在icu中被频繁使用。射线照相确认正确的放置位置是最佳的可用标准。根据Cochrane最近发表的一篇系统综述，超声检查作为一种单一的检查，在确认正确的位置方面准确性不足。研究问题：在两步的方法中，超声检查与胃上水平的动态雾化测试是否可靠，以确定正确的NGT位置？研究设计与方法本研究在瑞士的4个icu进行。超声检查包括2部分：颈部扫描和上腹部扫描加注射试验。出于安全考虑，只有在食管可见NGT的患者进行了注射检查的胃壁成像。我们考虑了3种注射试验结果：正确放置，不正确放置或不确定放置在胃中。诊断试验与参考标准的比较允许评估敏感性、特异性、阳性预测值、阴性预测值和准确性。结果有182例患者符合研究条件。平均年龄68岁，男性122例，肥胖42例，机械通气120例。10例患者因违反方案或未能观察到食管内的NGT而被排除在最终分析之外。动态雾化检测结果分别为阳性125例（73%）、阴性39例（22%）和不确定8例（5%）。排除不确定的结果，该试验灵敏度为79% (95% CI, 71.4% ~ 84.7%)，特异性为100% (95% CI, 47.8% ~ 100%)，阳性预测值为100% (95% CI, 97.1% ~ 100%)，阴性预测值为13% (95% CI, 4.3% ~ 27.4%)，准确率为79.3% （95% CI, 72.3% ~ 85.2%）。考虑到不确定的阳性和阴性结果，我们获得了类似的诊断测试性能。我们的研究结果表明，在ICU环境下，动态雾化试验是一种可靠的方法来确认胃内NGT的放置。它可以减少相当数量的患者对x线摄影的需求。临床试验注册网站clinicaltrials .gov；否。: NCT06693219;URL: www.clinicaltrials.gov

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引用次数: 0

Implementing Large Language Models in Critical Care 在重症监护中实现大型语言模型

CHEST critical care

Pub Date : 2025-05-24 DOI: 10.1016/j.chstcc.2025.100180

Khalil El Gharib MD

Large language models are artificial intelligence tools that have emerged in a supportive role in various fields, and we are on the cusp of witnessing their true potential in critical care medicine. In this article, we highlight the anticipated applications of these models in this setting, as well as the barriers that separate us from actualizing their deployment, ranging from pragmatic concerns, such as doubts in clinical decision-making, to ethical trustworthiness, along with means to attempt to mitigate these challenges.

大型语言模型是人工智能工具，在各个领域都发挥着支持作用，我们即将见证它们在重症监护医学中的真正潜力。在这篇文章中，我们强调了这些模型在这种情况下的预期应用，以及使我们无法实现其部署的障碍，从实际问题，如临床决策中的疑虑，到道德可信度，以及试图减轻这些挑战的方法。

引用次数: 0

The Diagnostic Accuracy of Serum Procalcitonin for Sepsis in Adult Patients in the Emergency Department 血清降钙素原对急诊成人脓毒症的诊断准确性

CHEST critical care

Pub Date : 2025-05-22 DOI: 10.1016/j.chstcc.2025.100179

Tanmoy Ghatak MD, PDCC, FACEE , Syed Ammar Sajjad MSc , Arnavjyoti Das MD , Anup Kumar MSc, PhD , Kurvatteppa Halemani MSc , Bram Rochwerg MD, FRCPC

Background

Procalcitonin, a precursor hormone of calcitonin, represents a promising marker of bacterial infections.

Research Question

What is the accuracy of procalcitonin for the diagnosis of sepsis in adult patients in the emergency department (ED)?

Study Design and Methods

In this this systematic review and meta-analysis, we searched 5 databases (PubMed, Google Scholar, Science Direct, Wiley, and the Cochrane database) from the inception of the Third International Consensus Definitions for Sepsis and Septic Shock diagnostic criteria (January 1, 2016) through December 31, 2024. We included studies that assessed the accuracy of procalcitonin for sepsis in adult patients admitted in the ED. We performed a random-effects meta-analysis, evaluated individual study risk of bias using Quality Assessment of Diagnostic Accuracy Studies 2 criteria and certainty of evidence using Grading of Recommendations, Assessment, Development, and Evaluations methodology.

Results

We included 11 studies comprising 7,937 patients in the analysis. The pooled sensitivity of procalcitonin for sepsis in patients in the ED was 0.62 (95% CI, 0.60-0.64) and the pooled specificity was 0.80 (95% CI, 0.79-0.81); both were based on low certainty evidence. The pooled positive likelihood ratio was 2.80 (95% CI, 2.20-3.57), the negative likelihood ratio was 0.42 (95% CI, 0.32-0.55), and the pooled diagnostic OR was 6.83 (95% CI, 4.87-9.58). The area under the summary receiver operating characteristic curve for procalcitonin was 0.77 (95% CI, 0.7281-0.8309).

Conclusions

Based on pooled analysis, procalcitonin was shown to have reasonable specificity but poor sensitivity for diagnosis of sepsis in patients in the ED with suspected infection. Given that the results are based on low certainty of evidence, further high-quality data in this population are needed.

Clinical Trial Registration

International Prospective Register of Systematic Reviews; No.: CRD42024618786; URL: https://www.crd.york.ac.uk/prospero/

降钙素原是降钙素的前体激素，是一种很有前景的细菌感染标志物。降钙素原在急诊科（ED）诊断成人脓毒症中的准确性是多少？研究设计和方法在这项系统评价和荟萃分析中，我们检索了5个数据库（PubMed， b谷歌Scholar， Science Direct， Wiley和Cochrane数据库），从第三次国际共识脓毒症和脓毒性休克诊断标准定义开始（2016年1月1日）到2024年12月31日。我们纳入了评估在急诊科住院的成年患者中降钙素原对脓毒症的准确性的研究。我们进行了随机效应荟萃分析，使用诊断准确性质量评估研究2标准评估个体研究的偏倚风险，并使用推荐、评估、发展和评估分级方法评估证据的确定性。结果我们纳入了11项研究，包括7,937例患者。降钙素原对ED患者脓毒症的综合敏感性为0.62 (95% CI, 0.60-0.64)，综合特异性为0.80 (95% CI, 0.79-0.81)；两者都是基于低确定性的证据。合并阳性似然比为2.80 (95% CI, 2.20-3.57)，合并阴性似然比为0.42 (95% CI, 0.32-0.55)，合并诊断OR为6.83 （95% CI, 4.87-9.58）。降钙素原的综合受试者工作特征曲线下面积为0.77 （95% CI, 0.7281-0.8309）。结论综合分析显示，降钙素原对疑似感染的ED患者诊断败血症具有合理的特异性，但敏感性较差。鉴于结果是基于低确定性的证据，需要在这一人群中进一步获得高质量的数据。临床试验注册国际前瞻性系统评价注册；否。: CRD42024618786;URL: https://www.crd.york.ac.uk/prospero/

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引用次数: 0

Protocol and Statistical Analysis Plan for a Multicenter Randomized Trial of Ketamine vs Etomidate for Emergency Tracheal Intubation 氯胺酮与依托咪酯用于紧急气管插管的多中心随机试验方案和统计分析计划

CHEST critical care

Pub Date : 2025-05-21 DOI: 10.1016/j.chstcc.2025.100177

Stephanie C. DeMasi MD , Brant Imhoff MS , Ariel A. Lewis BSN, RN, MPH , Kevin P. Seitz MD , Brian E. Driver MD , Kevin W. Gibbs MD , Adit A. Ginde MD, MPH , Stacy A. Trent MD, MPH , Derek W. Russell MD , Amelia L. Muhs MD , Matthew E. Prekker MD, MPH , John P. Gaillard MD , Daniel Resnick-Ault MD , L. Jane Stewart MD, JD, MPH , Micah R. Whitson MD , Graham W.W. Van Schaik MD, MBA , Aaron E. Robinson MD, MPH , Jessica A. Palakshappa MD , Neil R. Aggarwal MD, MHSc , Jason C. Brainard MD , Matthew W. Semler MD

Background

Emergency tracheal intubation is a common and high-risk procedure. Ketamine and etomidate are medicines commonly used to induce anesthesia for emergency tracheal intubation, but whether the induction medication used affects patient outcomes is uncertain.

Research Question

Does the use of ketamine for induction of anesthesia decrease the incidence of death among adults undergoing emergency tracheal intubation compared with the use of etomidate?

Study Design and Methods

The Randomized Trial of Sedative Choice for Intubation (RSI) is a pragmatic, multicenter, unmasked, parallel-group randomized trial being conducted at 14 sites (6 emergency departments and 8 ICUs) in the United States. The trial compares ketamine vs etomidate for induction of anesthesia among 2,364 critically ill adults undergoing emergency tracheal intubation. The primary outcome is all-cause 28-day in-hospital mortality. The secondary outcome is the incidence of cardiovascular collapse during intubation, a composite of hypotension, receipt of vasopressors, and cardiac arrest.

Results

Enrollment began on April 6, 2022, and is expected to conclude in 2025.

Interpretation

The RSI will provide important data on the effects of ketamine vs etomidate on death and other outcomes for critically ill adults undergoing emergency tracheal intubation. Specifying the protocol and statistical analysis plan before the conclusion of enrollment increases the rigor, reproducibility, and transparency of the trial.

Clinical Trial Registration

ClinicalTrials.gov; No.: NCT05277896; URL: www.clinicaltrials.gov

背景：紧急气管插管是一种常见且高风险的手术。氯胺酮和依托咪酯是紧急气管插管中常用的诱导麻醉药物，但所使用的诱导药物是否会影响患者的预后尚不确定。研究问题：与使用依托咪酯相比，使用氯胺酮诱导麻醉是否能降低急诊气管插管成人的死亡率？研究设计和方法插管镇静选择随机试验（RSI）是一项实用的、多中心的、公开的、平行组的随机试验，在美国的14个地点（6个急诊科和8个icu）进行。该试验比较了氯胺酮和依托咪酯在2364名接受紧急气管插管的危重成人中诱导麻醉的效果。主要结局是全因住院28天死亡率。次要结局是插管期间心血管衰竭的发生率、低血压、接受血管加压药物和心脏骤停的复合。试验于2022年4月6日开始，预计于2025年结束。RSI将提供氯胺酮与依托咪酯对急诊气管插管危重成人死亡和其他结局影响的重要数据。在登记结束前明确方案和统计分析计划，增加了试验的严谨性、可重复性和透明度。临床试验注册网站clinicaltrials .gov；否。: NCT05277896;URL: www.clinicaltrials.gov

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引用次数: 0

Association of Musculoskeletal Indexes With 1-Year Outcomes After ≥ 7 Days of Mechanical Ventilation 机械通气≥7天后肌肉骨骼指标与1年预后的关系

CHEST critical care

Pub Date : 2025-05-21 DOI: 10.1016/j.chstcc.2025.100176

Hannah Wozniak MD , Erminio Santangelo , Micheal McInnis , Laura Dragoi , Priscila Robles , Leslie M. Chu , Andrea Matte , Margaret S. Herridge

<div><h3>Background</h3><div>In critically ill patients, musculoskeletal indexes have been associated with short-term outcomes such as in-hospital mortality and discharge disposition. Their influence on long-term outcomes in chronically critically ill patients remains unclear.</div></div><div><h3>Research Question</h3><div>Does an association exist between musculoskeletal indexes and 1-year mortality in chronically critically ill patients? Are these indexes also associated with 7-day post-ICU functional independence measure (FIM) and discharge disposition?</div></div><div><h3>Study Design and Methods</h3><div>This study used the Canadian Outcomes and Needs Assessment in Intensive Care Unit (ICU) Survivors of Prolonged Mechanical Ventilation and Their Caregivers (RECOVER) phase 1 cohort of patients requiring mechanical ventilation for ≥ 7 days. Patients who underwent abdominal CT imaging within the first 14 days of ICU admission were included. Skeletal muscle index (SMI), psoas muscle index (PMI), and trabecular bone density (BD) were measured at the L3 vertebral level. Multivariable logistic regression assessed the association between each index and 1-year mortality; multivariable linear regression assessed the association with 7-day post-ICU FIM. A Kruskal-Wallis H test compared musculoskeletal indexes across 4 discharge disposition groups.</div></div><div><h3>Results</h3><div>One hundred patients were included; the median age was 57 years (interquartile range [IQR], 45-65 years), and 43% were female. Those who did not survive by 1 year showed lower musculoskeletal indexes than survivors: median SMI, 28.8 cm<sup>2</sup>/m<sup>2</sup> (IQR, 22-34 cm<sup>2</sup>/m<sup>2</sup>) vs 33.5 cm<sup>2</sup>/m<sup>2</sup> (IQR, 25.7-44.1 cm<sup>2</sup>/m<sup>2</sup>; <em>P</em> = .03); median PMI, 3.3 cm<sup>2</sup>/m<sup>2</sup> (IQR, 2.5-4.5 cm<sup>2</sup>/m<sup>2</sup>) vs 4 cm<sup>2</sup>/m<sup>2</sup> (IQR, 3.2-5.6 cm<sup>2</sup>/m<sup>2</sup>; <em>P</em> = .02); and median BD, 131 Hounsfield units (HU; IQR, 100-196 HU) vs 175 HU (IQR, 131-220 HU; <em>P</em> < .01). Lower SMI (OR per 10-unit decrease, 2.00; 95% CI, 1.21-3.33; <em>P</em> < .01), PMI (OR per 1-unit decrease, 1.54; 95% CI, 1.06-2.23; <em>P</em> = .02), and BD (OR per 10-unit decrease, 1.10; 95% CI, 1.01-1.20; <em>P</em> = .05) were associated significantly with 1-year mortality. No significant association was found between musculoskeletal indexes and FIM 7 days after ICU stay. Significant differences in SMI were found across discharge groups (χ<sup>2</sup> (3) = 7.882; <em>P</em> = .048).</div></div><div><h3>Interpretation</h3><div>The results of this study suggest that decreased musculoskeletal indexes are associated with 1-year mortality in chronically critically ill patients. These findings may help to inform clinical decision-making.</div></div><div><h3>Clinical Trial Registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>; No.: <span><span>NC

在危重患者中，肌肉骨骼指标与短期预后相关，如住院死亡率和出院处置。它们对慢性危重病人长期预后的影响尚不清楚。研究问题：慢性危重症患者的肌肉骨骼指数与1年死亡率之间是否存在关联？这些指标是否也与icu后7天功能独立测量（FIM）和出院处置相关？研究设计和方法本研究采用加拿大重症监护病房（ICU）延长机械通气幸存者及其护理人员（RECOVER） 1期队列结果和需求评估，患者需要机械通气≥7天。纳入在ICU入院前14天内接受腹部CT成像的患者。在L3椎体水平测量骨骼肌指数（SMI）、腰肌指数（PMI）和骨小梁骨密度（BD）。多变量logistic回归评估各指标与1年死亡率之间的相关性；多变量线性回归评估与icu后7天FIM的关系。Kruskal-Wallis H测试比较了4个出院处置组的肌肉骨骼指数。结果纳入100例患者；中位年龄为57岁（四分位间距[IQR]， 45-65岁），43%为女性。未存活1年的患者肌肉骨骼指数低于存活者：中位SMI为28.8 cm2/m2 (IQR, 22-34 cm2/m2) vs 33.5 cm2/m2 (IQR, 25.7-44.1 cm2/m2)；P = .03)；PMI中位数，3.3 cm2/m2 (IQR, 2.5-4.5 cm2/m2) vs 4 cm2/m2 (IQR, 3.2-5.6 cm2/m2)；P = .02)；中位BD为131 Hounsfield单位(HU；IQR, 100-196 HU) vs 175 HU (IQR, 131-220 HU；P & lt;. 01)。较低的SMI(每10个单位减少的OR， 2.00；95% ci, 1.21-3.33；P & lt;.01)， PMI(每减少1个单位的OR， 1.54；95% ci, 1.06-2.23；P = 0.02)和BD(每减少10个单位的OR为1.10；95% ci, 1.01-1.20；P = 0.05)与1年死亡率显著相关。ICU住院后7天，肌肉骨骼指标与FIM无显著相关性。各出院组SMI差异有统计学意义(χ2 (3) = 7.882；P = .048)。本研究结果提示，慢性危重症患者的1年死亡率与肌肉骨骼指数下降有关。这些发现可能有助于临床决策。临床试验注册网站clinicaltrials .gov；否。: NCT00896220;URL: www.clinicaltrials.gov

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引用次数: 0

Protocol and Statistical Analysis Plan for the Vasopressin for Septic Shock Pragmatic (VASSPR) Cluster-Crossover Randomized Trial 抗利尿激素治疗感染性休克实用（VASSPR）集群-交叉随机试验的方案和统计分析计划

CHEST critical care

Pub Date : 2025-05-21 DOI: 10.1016/j.chstcc.2025.100178

Ithan D. Peltan MD , Danielle Groat PhD , Jason R. Jacobs PhD , Elisabeth H. Tillman BS , Ben J. Brintz PhD , Stephanie Chauv PharmD, BCCCP , Sarah J. Beesley MD , Jennifer H. Edwards MD , Natalia Arizmendez MD , Eliotte L. Hirshberg MD , Jason R. Carr MD , Michael J. Lanspa MD , Joseph R. Bledsoe MD , Austin T. Smith MD , Harmony Schneider PharmD , Ping Hu MCS , Tamara D. Moores Todd MD , Carolyn Klippel BS , Matthew W. Semler MD , Jonathan W. Casey MD , Lindsay M. Leither DO

Background

Guidelines recommend vasopressin as the preferred second-line vasopressor for treatment of septic shock. However, the optimal threshold for vasopressin initiation is unclear.

Research Question

Does a treatment strategy using a lower or a higher threshold for initiation of vasopressin as a secondary vasopressor decrease the incidence of 28-day mortality for patients with septic shock?

Study Design and Methods

The Vasopressin for Septic Shock Pragmatic (VASSPR) trial is a multicenter, open-label, cluster-randomized, multiple cluster-crossover pragmatic clinical trial being conducted in 13 hospitals in Utah and Idaho. The trial compares a strategy for septic shock management recommending initiation of fixed-dose vasopressin as a secondary vasopressor at a lower threshold (when the total dose of other vasopressors reaches 0.1 μg/kg/min norepinephrine equivalents [NEEs]) to a strategy initiating vasopressin at a higher threshold (when other vasopressors reach 0.4 μg/kg/min NEEs). All adult patients with septic shock at study hospitals are enrolled in the trial and assigned to the treatment strategy in place at the study hospital when and where they start vasopressor treatment for suspected or confirmed septic shock. Individual patient care, including adherence to the assigned vasopressin initiation strategy, occurs at the discretion of each patient’s treating clinicians. The primary outcome is 28-day all-cause mortality. The key secondary outcome is renal replacement therapy-free days to day 28.

Results

This article describes the protocol and statistical analysis plan for the conduct and analysis of the VASSPR trial.

Interpretation

The VASSPR trial will provide important data to guide vasopressor management for patients with septic shock. Prespecification of the trial protocol and statistical analysis plan before completion of enrollment is important for rigorous trial conduct and reporting.

Clinical Trial Registration

ClinicalTrials.gov; No.: NCT06217562; URL: www.clinicaltrials.gov

背景：指南推荐抗利尿激素作为治疗感染性休克的首选二线抗利尿激素。然而，抗利尿激素起始的最佳阈值尚不清楚。使用较低或较高的抗利尿激素起始阈值作为继发性抗利尿激素的治疗策略是否能降低感染性休克患者28天死亡率？研究设计和方法抗利尿激素治疗感染性休克临床试验（VASSPR）是一项多中心、开放标签、集群随机、多集群交叉的临床试验，在犹他州和爱达荷州的13家医院进行。该试验比较了一种脓毒性休克管理策略，建议在较低阈值（当其他血管加压素总剂量达到0.1 μg/kg/min去甲肾上腺素当量[NEEs]时）开始使用固定剂量的血管加压素作为继发血管加压素，与在较高阈值（当其他血管加压素达到0.4 μg/kg/min NEEs时）开始使用血管加压素。所有在研究医院患有感染性休克的成年患者都被纳入试验，并被分配到研究医院的治疗策略中，他们在何时何地开始对疑似或确诊的感染性休克进行血管加压治疗。个别患者护理，包括遵守指定的抗利尿激素起始策略，由每位患者的治疗临床医生自行决定。主要终点是28天全因死亡率。关键的次要结局是无肾替代治疗的第28天。结果本文描述了VASSPR试验进行和分析的方案和统计分析计划。结论：VASSPR试验将为指导感染性休克患者的血管加压药物管理提供重要数据。在完成入组前预先制定试验方案和统计分析计划对于严格的试验进行和报告是重要的。临床试验注册网站clinicaltrials .gov；否。: NCT06217562;URL: www.clinicaltrials.gov

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引用次数: 0