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Predicting Secondary Hemophagocytic Lymphohistiocytosis in Adult Patients with Scrub Typhus and Its Prognostic Significance. 恙虫病成人患者继发性嗜血细胞淋巴组织细胞增多症的预测及其预后意义
IF 1.5 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-09-01 Epub Date: 2024-08-31 DOI: 10.5005/jp-journals-10071-24787
Suresh Selvam, Akshit Tuli, Kumar P Yuvasai, Shashikant Saini, Sathvik R Erla, Jyotdeep Kaur, Manisha Biswal, Navneet Sharma, Ashok K Pannu

Objective: Secondary hemophagocytic lymphohistiocytosis (sHLH) is an increasingly recognized complication in patients with scrub typhus, potentially contributing to substantial mortality despite appropriate antibiotic treatment. This study aims to determine the prevalence and prognosis of sHLH and identify diagnostic factors in adult patients with scrub typhus in North India.

Methods: This prospective cohort study was conducted at PGIMER, Chandigarh, from August 2021 to November 2023. sHLH was defined as an HScore of 200 or above. The diagnostic performance of biomarkers such as ferritin, fibrinogen, triglycerides, and C-reactive protein was assessed through receiver operating characteristic curve analysis, evaluating area under the curve (AUC), sensitivity, and specificity.

Results: Out of 150 patients (mean age 39 years, 54% female), 28 (18.7%) were diagnosed with sHLH. Those presenting with high-grade fever, seizures, high pulse rate, hepatomegaly, splenomegaly, cytopenia, and significant hepatic dysfunction were more likely to have sHLH. Ferritin demonstrated the highest diagnostic utility (AUC 0.83), compared to fibrinogen (AUC 0.72), triglyceride (AUC 0.67), and C-reactive protein (AUC 0.69). The optimal cutoff for ferritin was 2000 ng/mL, with a sensitivity of 90% and a specificity of 66%. Higher ferritin thresholds (6000 ng/mL and 10000 ng/mL) increased specificity to 88% and 95%, respectively. Patients with sHLH often presented with multi-organ failure, necessitating mechanical ventilation and vasopressor support. In-hospital mortality was significantly higher in sHLH patients than in those without (21.4% vs 6.6%, p = 0.025).

Conclusion: Early detection of sHLH using the HScore and ferritin significantly influences the management of scrub typhus, underscoring the necessity for tailored therapeutic strategies to improve patient outcomes.

How to cite this article: Selvam S, Tuli A, Yuvasai KP, Saini S, Erla SR, Kaur J, et al. Predicting Secondary Hemophagocytic Lymphohistiocytosis in Adult Patients with Scrub Typhus and Its Prognostic Significance. Indian J Crit Care Med 2024;28(9):823-831.

目的:继发性嗜血细胞淋巴组织细胞增多症(sHLH继发性嗜血细胞淋巴组织细胞增多症(sHLH)是恙虫病患者中一种日益被认可的并发症,尽管经过适当的抗生素治疗,但仍有可能导致大量死亡。本研究旨在确定sHLH的发病率和预后,并确定北印度恙虫病成年患者的诊断因素:这项前瞻性队列研究于 2021 年 8 月至 2023 年 11 月在昌迪加尔的 PGIMER 进行。通过接收器工作特征曲线分析评估了铁蛋白、纤维蛋白原、甘油三酯和 C 反应蛋白等生物标志物的诊断性能,评价了曲线下面积(AUC)、灵敏度和特异性:在 150 名患者(平均年龄 39 岁,54% 为女性)中,28 人(18.7%)被确诊为 sHLH。伴有高热、癫痫发作、高脉搏率、肝肿大、脾肿大、全血细胞减少和明显肝功能异常的患者更有可能患有 sHLH。与纤维蛋白原(AUC 0.72)、甘油三酯(AUC 0.67)和 C 反应蛋白(AUC 0.69)相比,铁蛋白的诊断效用最高(AUC 0.83)。铁蛋白的最佳临界值为 2000 纳克/毫升,灵敏度为 90%,特异性为 66%。更高的铁蛋白临界值(6000 纳克/毫升和 10000 纳克/毫升)可将特异性分别提高到 88% 和 95%。sHLH患者通常会出现多器官功能衰竭,需要机械通气和血管加压支持。sHLH患者的院内死亡率明显高于非sHLH患者(21.4% vs 6.6%,P = 0.025):结论:使用HScore和铁蛋白及早检测出sHLH对恙虫病的治疗有重大影响,强调有必要制定有针对性的治疗策略以改善患者预后:Selvam S, Tuli A, Yuvasai KP, Saini S, Erla SR, Kaur J, et al.Indian J Crit Care Med 2024;28(9):823-831.
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引用次数: 0
Protocolized Regional Citrate Anticoagulation during Continuous Renal Replacement Therapy: A Single Center Experience. 持续肾脏替代疗法期间的区域性枸橼酸盐抗凝治疗方案:单中心经验
IF 1.5 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-09-01 Epub Date: 2024-08-31 DOI: 10.5005/jp-journals-10071-24797
Anant V Pachisia, G Praveen Kumar, Rahul Harne, K N Jagadeesh, Sweta J Patel, Divya Pal, Pooja Tyagi, Swagat Pattajoshi, Keerti Brar, Parimal B Patel, Ronak Zatakiya, Subhash Chandra, Deepak Govil

Background: Regional citrate anticoagulation (RCA) has emerged as a treatment modality that reduces bleeding risk and filter clotting. With initial experience of using RCA with continuous renal replacement therapy (CRRT), we have formulated a working protocol based on published literature.

Objective: The study aimed to evaluate the protocol for routine use of RCA during CRRT requiring anticoagulation and evaluation of filter life.

Methodology: It is a single-center, open-label, prospective, non-randomized, non-interventional, single-arm, observational study conducted at a tertiary care hospital between September 2022 and July 2023. All adult patients with acute kidney injury (AKI) or hyperammonemia requiring CRRT and necessitating the use of anticoagulation were enrolled in the study. The study used Prisma Flex M100 AN 69 dialyzer on Prisma Flex (Baxter) CRRT machines during continuous venovenous hemodiafiltration (CVVHDF). The targeted CRRT dose in all the study patients was 25-30 mL/kg/hour. Based on the published literature, we have developed a working protocol (Appendix 1) for managing patients on CRRT using RCA.

Results: A total of 159 patients were analyzed for the study. The median [interquartile range (IQR)] filter life using RCA was 30 (12-55) hours. Filter clotting was observed in 33.3% of patients. Citrate accumulation was present in 52.25% of patients, but no CRRT was discontinued as citrate accumulation resolved after following the corrective steps in the protocol. None of the patients had citrate toxicity. Chronic liver disease (CLD) (p ≤ 0.001) and those who were post-living donor liver transplant recipients (p = 0.004) had a statistically significant increase in citrate accumulation. Also, patients who had higher lactate at baseline (6 hours post-CRRT initiation), had a higher chance of citrate accumulation.

Conclusion: Our RCA protocol provides a safe approach to regional anticoagulation during CRRT in critically ill patients.

How to cite this article: Pachisia AV, Kumar GP, Harne R, Jagadeesh KN, Patel SJ, Pal D, et al. Protocolized Regional Citrate Anticoagulation during Continuous Renal Replacement Therapy: A Single Center Experience. Indian J Crit Care Med 2024;28(9):859-865.

背景:区域性枸橼酸盐抗凝(RCA)已成为一种可降低出血风险和过滤凝血的治疗方式。根据在持续肾脏替代治疗(CRRT)中使用 RCA 的初步经验,我们根据已发表的文献制定了一套工作方案:该研究旨在评估在需要抗凝的 CRRT 期间常规使用 RCA 的方案,并评估过滤器的使用寿命:这是一项单中心、开放标签、前瞻性、非随机、非干预、单臂、观察性研究,于2022年9月至2023年7月在一家三级医院进行。所有患有急性肾损伤(AKI)或高氨血症、需要进行 CRRT 且必须使用抗凝药物的成年患者均被纳入研究。研究使用 Prisma Flex (Baxter) CRRT 机上的 Prisma Flex M100 AN 69 透析器进行连续静脉血液透析(CVVHDF)。所有研究患者的 CRRT 目标剂量均为 25-30 毫升/千克/小时。根据已发表的文献,我们制定了使用 RCA 管理 CRRT 患者的工作方案(附录 1):本研究共分析了 159 名患者。使用 RCA 的过滤器寿命中位数[四分位数间距 (IQR)]为 30 (12-55) 小时。33.3%的患者观察到过滤器凝结。52.25%的患者出现了枸橼酸盐蓄积,但由于枸橼酸盐蓄积在按照方案采取纠正措施后得到缓解,因此没有患者停止 CRRT。没有一名患者出现枸橼酸盐中毒。慢性肝病(CLD)(p ≤ 0.001)和接受活体肝移植后的患者(p = 0.004)的枸橼酸盐蓄积有显著的统计学意义。此外,基线(CRRT 开始后 6 小时)乳酸较高的患者出现枸橼酸盐蓄积的几率也较高:我们的 RCA 方案为重症患者在 CRRT 期间进行区域抗凝提供了一种安全的方法:Pachisia AV, Kumar GP, Harne R, Jagadeesh KN, Patel SJ, Pal D, et al:单中心经验。Indian J Crit Care Med 2024;28(9):859-865.
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引用次数: 0
Left Ventricular Diastolic Dysfunction in the Critically Ill: The Rubik's Cube of Echocardiography. 重症患者的左心室舒张功能障碍:超声心动图的魔方。
IF 1.5 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-09-01 Epub Date: 2024-08-31 DOI: 10.5005/jp-journals-10071-24801
Vivek Kumar

How to cite this article: Kumar V. Left Ventricular Diastolic Dysfunction in the Critically Ill: The Rubik's Cube of Echocardiography. Indian J Crit Care Med 2024;28(9):813-815.

如何引用本文:Kumar V. 重症患者的左心室舒张功能障碍:超声心动图的魔方。Indian J Crit Care Med 2024;28(9):813-815.
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引用次数: 0
"Financially Palliative": The Need to Address a Perplexing Financial Conundrum in Emergency and Critical Care. "财政上的姑息":需要解决急诊和重症监护中令人困惑的财务难题。
IF 1.5 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-09-01 Epub Date: 2024-08-31 DOI: 10.5005/jp-journals-10071-24786
Rachana Bhat, Akshaya Ramaswami

The terminology "Financially Palliative" is a pseudonym and refers to a unique challenge faced in countries where public healthcare insurance coverage is not robust and the percentage of out-of-pocket health expenditure continues to be high. Emergency and critical care healthcare expenditures in such circumstances usually pose additional burden as they are unforeseen expenses, disproportionately high, for which most people are unprepared. Such situations may lead into a vicious cycle that initiates with expenditure hesitancy and delay in definitive care, which in turn leads to deterioration in the patient's condition and delay-related complications. This further fuels expenditure hesitancy due to uncertain prognosis and outcomes. The future threats posed by this issue are manifold, which are not only restricted to poor patient outcomes and diminishing physician morale but also hinder progress in science by influencing research outcomes/endpoints in areas where it is highly prevalent. Identifying and defining the problem with terminology is only the first step in working towards solutions. The issue needs to be addressed and mitigated before it spreads its roots deeper into our healthcare system.

How to cite this article: Bhat R, Ramaswami A. "Financially Palliative": The Need to Address a Perplexing Financial Conundrum in Emergency and Critical Care. Indian J Crit Care Med 2024;28(9):820-822.

财政姑息 "是一个化名,指的是在公共医疗保险覆盖率不高、自付医疗费用比例持续较高的国家所面临的独特挑战。在这种情况下,急诊和危重病人的医疗支出通常会造成额外负担,因为这些支出是不可预见的,而且不成比例地高,大多数人对此毫无准备。这种情况可能会导致恶性循环,首先是支出犹豫不决,延误最终治疗,进而导致病人病情恶化和与延误有关的并发症。由于预后和结果不确定,这进一步加剧了支出犹豫。这一问题对未来造成的威胁是多方面的,不仅限于患者的不良预后和医生士气的低落,还通过影响高发领域的研究成果/终点而阻碍科学进步。发现和界定术语问题只是努力解决问题的第一步。我们需要在这个问题深入医疗系统之前加以解决和缓解:Bhat R, Ramaswami A. "Financially Palliative":解决急诊和重症监护中令人困惑的财务难题的必要性。Indian J Crit Care Med 2024;28(9):820-822.
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引用次数: 0
Pediatric Sepsis - Sailing the Unchartered Waters with Omics. 小儿败血症--利用 Omics 技术在未知水域航行。
IF 1.5 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-09-01 Epub Date: 2024-08-31 DOI: 10.5005/jp-journals-10071-24799
Mullai Baalaaji

How to cite this article: Baalaaji M. Pediatric Sepsis - Sailing the Unchartered Waters with Omics. Indian J Crit Care Med 2024;28(9):818-819.

如何引用本文:Baalaaji M. Pediatric Sepsis - Sailing the Unchartered Waters with Omics.Indian J Crit Care Med 2024;28(9):818-819.
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引用次数: 0
Author Response: Oxygenation Indices in Adult COVID ARDS Patients. 作者回复:成人 COVID ARDS 患者的氧合指数。
IF 1.5 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-09-01 Epub Date: 2024-08-31 DOI: 10.5005/jp-journals-10071-24790
Sonali Mr Vadi, Neha Sanwalka, Durga Suthar

How to cite this article: Vadi SMR, Sanwalka N, Suthar D. Author Response: Oxygenation Indices in Adult COVID ARDS Patients. Indian J Crit Care Med 2024;28(9):889.

本文引用方式Vadi SMR, Sanwalka N, Suthar D. Author Response:成人 COVID ARDS 患者的氧合指数。Indian J Crit Care Med 2024;28(9):889.
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引用次数: 0
Prevalence and Outcomes of Carbamazepine Toxicity in the Emergency Department: A Single-center Retrospective Study. 急诊科中卡马西平中毒的发生率和结果:单中心回顾性研究
IF 1.5 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-09-01 Epub Date: 2024-08-31 DOI: 10.5005/jp-journals-10071-24795
Darpanarayan Hazra, Nejah F Ellouze, Suad A Abri

Background: Carbamazepine (CBX) is widely used for various medical conditions, but its associated toxicity poses significant clinical concerns. This study aims to provide insights into the clinical presentations, management strategies, and outcomes of CBX toxicity cases in an emergency department (ED) setting.

Methodology: This was a 10-year retrospective cohort chart review study, including all patients with elevated CBX levels. Data on clinical features, CBX levels, laboratory findings, electrocardiograms (ECGs), patient management, and outcomes were analyzed. Cases were categorized as acute or chronic toxicity.

Results: Out of the 1,965 medical charts reviewed, we included 70 patients with CBX levels above the therapeutic range (prevalence: 3.6%). Chronic CBX toxicity cases (55.7%) were predominant, with gastrointestinal (GI) symptoms being the most common. Most patients presented with isolated CBX overdoses (88.6%), while mixed overdoses (11.4%) were less frequent. Patients were categorized based on CBX levels: 44 had mild toxicity (>51 μmol/L), and 26 had moderate toxicity (>85 μmol/L). Within the mild group, 15 patients experienced acute toxicity, compared to 16 patients in the moderate group. Four patients who had mixed overdoses and low sensorium required intubation and mechanical ventilation. Three patients received activated charcoal (AC), and another 3 patients received multiple doses of AC to reduce drug absorption. The majority of patients (65.7%) required hospital admission, underscoring the seriousness of CBX toxicity. There were no fatalities among these 70 patients.

Conclusion: This study emphasizes the importance of a systematic approach to assessing and managing CBX toxicity, considering its diverse clinical presentations and variations in serum CBX levels.

How to cite this article: Hazra D, Ellouze NF, Abri SA. Prevalence and Outcomes of Carbamazepine Toxicity in the Emergency Department: A Single-center Retrospective Study. Indian J Crit Care Med 2024;28(9):866-870.

背景:卡马西平(CBX卡马西平(CBX)被广泛用于治疗各种内科疾病,但其相关毒性引起了严重的临床问题。本研究旨在深入了解急诊科(ED)中卡马西平毒性病例的临床表现、管理策略和治疗效果:这是一项为期 10 年的回顾性队列病历审查研究,包括所有 CBX 水平升高的患者。研究分析了临床特征、CBX 水平、实验室检查结果、心电图(ECG)、患者管理和治疗结果等数据。病例被分为急性和慢性中毒:结果:在1965 份病历中,有 70 名患者的 CBX 水平超过了治疗范围(发病率:3.6%)。慢性 CBX 中毒病例(55.7%)占大多数,其中胃肠道症状最为常见。大多数患者表现为单独的 CBX 过量(88.6%),而混合过量(11.4%)则较少见。根据 CBX 水平对患者进行了分类:44 例轻度中毒(>51 μmol/L),26 例中度中毒(>85 μmol/L)。在轻度组中,15 名患者出现急性毒性,而在中度组中,16 名患者出现急性毒性。四名混合过量和神志不清的患者需要插管和机械通气。三名患者服用了活性炭(AC),另有三名患者服用了多剂量的活性炭以减少药物吸收。大多数患者(65.7%)需要入院治疗,这凸显了 CBX 药物中毒的严重性。这 70 名患者中没有死亡病例:本研究强调了系统评估和管理CBX毒性的重要性,同时考虑到了其不同的临床表现和血清CBX水平的变化:Hazra D, Ellouze NF, Abri SA.急诊科卡马西平中毒的发病率和结果:单中心回顾性研究。Indian J Crit Care Med 2024;28(9):866-870.
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引用次数: 0
Epidemiology and Long-term Outcomes of Acute Kidney Injury in Adult Patients with Perforation Peritonitis Undergoing Emergency Laparotomy. 接受急诊腹腔镜手术的穿孔性腹膜炎成人患者急性肾损伤的流行病学和长期疗效。
IF 1.5 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-09-01 Epub Date: 2024-08-31 DOI: 10.5005/jp-journals-10071-24796
Pallavi Priya, Dalim K Baidya, Rahul K Anand, Bikash R Ray, Puneet Khanna, Asuri Krishna, Souvik Maitra

Background: Reported incidence of acute kidney injury (AKI) is around 5.0-7.5% of all hospitalized patients, and 40% of them are postoperative patients. Major abdominal surgeries account for 3.1-35% of cases of postoperative AKI in various series. The aim of the study was to identify the incidence and risk factors of AKI in peritonitis patients undergoing emergency laparotomy.

Materials and methods: Adult patients aged 18-65 years undergoing emergency laparotomy for perforation peritonitis were included in this prospective observational study. Baseline clinical and laboratory data, intraoperative details and postoperative outcome data (AKI at day 7, length of intensive care unit and hospital stay, and mortality) were recorded. Logistic regression model was constructed to predict AKI at day 7.

Results: N = 140 patients were included in this study and 69 patients (49.3%) developed AKI within day 7. Larger volume of crystalloid [OR (95% CI) 1.00 (1.00-1.00); p = 0.012], intraoperative vasopressor use (OR 7.42 (2.41-22.83); p < 0.001), intraoperative blood loss [OR 1.004(1.00-1.01); p = 0.003] and the presence of chronic liver disease (CLD) [OR 22.44 (1.68-299.26); p = 0.019] were risk factors for the development of AKI. Acute kidney injury patients had increased mortality at day 90 (24.6% vs 1.4%; p < 0.001), length of ICU stay (3 days vs 0 days, p < 0.001), and length of hospital stay (11 days vs 7 days; p < 0.001).

Conclusion: In peritonitis patients undergoing emergency laparotomy, as many as 49% of patients develop AKI within 1 week. The presence of CLD, intraoperative blood loss, and the use of crystalloids and vasopressor increase the odds of developing AKI.

How to cite this article: Priya P, Baidya DK, Anand RK, Ray BR, Khanna P, Krishna A, et al. Epidemiology and Long-term Outcomes of Acute Kidney Injury in Adult Patients with Perforation Peritonitis Undergoing Emergency Laparotomy. Indian J Crit Care Med 2024;28(9):854-858.

背景:据报道,在所有住院病人中,急性肾损伤(AKI)的发病率约为 5.0-7.5%,其中 40% 为术后病人。在各种系列的术后 AKI 病例中,腹部大手术占 3.1-35%。该研究旨在确定接受急诊开腹手术的腹膜炎患者 AKI 的发生率和风险因素:这项前瞻性观察研究纳入了因腹膜炎穿孔而接受急诊开腹手术的 18-65 岁成人患者。研究记录了基线临床和实验室数据、术中细节和术后结果数据(第7天的AKI、重症监护室和住院时间以及死亡率)。建立了逻辑回归模型来预测第7天的AKI:本研究共纳入 140 名患者,其中 69 名患者(49.3%)在术后第 7 天出现了 AKI。较大的晶体液用量[OR (95% CI) 1.00 (1.00-1.00); p = 0.012]、术中使用血管加压药(OR 7.42 (2.41-22.83); p < 0.001)、术中失血[OR 1.004(1.00-1.01); p = 0.003]和存在慢性肝病(CLD)[OR 22.44 (1.68-299.26); p = 0.019]是发生急性肾损伤的危险因素。急性肾损伤患者第90天的死亡率(24.6% vs 1.4%;P < 0.001)、重症监护室住院时间(3天 vs 0天,P < 0.001)和住院时间(11天 vs 7天;P < 0.001)均有所增加:结论:在接受急诊开腹手术的腹膜炎患者中,多达49%的患者会在1周内发生AKI。结论:在接受急诊开腹手术的腹膜炎患者中,多达49%的患者会在1周内发生AKI,CLD的存在、术中失血以及晶体液和血管加压剂的使用都会增加发生AKI的几率:Priya P、Baidya DK、Anand RK、Ray BR、Khanna P、Krishna A 等:《急诊腹腔镜手术穿孔性腹膜炎成人患者急性肾损伤的流行病学和长期预后》。Indian J Crit Care Med 2024;28(9):854-858.
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引用次数: 0
Profiling Molecular Changes of Host Response to Predict Outcome in Children with Septic Shock. 剖析宿主反应的分子变化以预测脓毒性休克患儿的预后
IF 1.5 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-09-01 Epub Date: 2024-08-31 DOI: 10.5005/jp-journals-10071-24789
A V Lalitha, Anil Vasudevan, Manju Moorthy, Gopalakrishna Ramaswamy

Background: Septic shock is associated with high mortality and there is significant heterogeneity in the host response. The aim of this study was to understand the genome-wide expression transcriptomic signatures in children with septic shock and correlate them with outcomes.

Methods: This was a prospective study conducted on children (aged 1 month to 18 years) admitted to the PICU (June-December 2021) with septic shock. Demographic details, clinical details, and administered treatment were collected. Differential gene expression analysis was performed to understand the genes and pathways affecting in different subjects.

Results: Fifteen patients were recruited (Septic shock survivors (n = 5), nonsurvivors (n = 5), and non-sepsis controls (n = 5). The median age of the patients in survivors and nonsurvivors was 15 (13, 24) months and 180 (180, 184) months, respectively. The sepsis-survivors vs nonsepsis possessed 983 upregulated and 624 downregulated genes while comparing sepsis nonsurvivors (SNS) with nonsepsis yielded 1,854 upregulated and 1,761 downregulated genes. Further, the lowest number of deregulated genes (383 upregulated and 486 downregulated) were present in SNS compared to sepsis survivors. The major Reactome pathways, found upregulated in SNSs relative to survivors included CD22 mediated B cell receptor (BCR) regulation, scavenging of heme from plasma, and creation of C4 and C2 activators while T cell receptor (TCR) signaling, the common pathway of fibrin clot formation and generation of second messenger molecules were found to be downregulated.

Conclusion: Mortality-related gene signatures are promising diagnostic biomarkers for pediatric sepsis.

How to cite this article: Lalitha AV, Vasudevan A, Moorthy M, Ramaswamy G. Profiling Molecular Changes of Host Response to Predict Outcome in Children with Septic Shock. Indian J Crit Care Med 2024;28(9):879-886.

背景:脓毒性休克与高死亡率有关,而宿主反应存在显著的异质性。本研究旨在了解脓毒性休克患儿的全基因组表达转录组特征,并将其与预后相关联:这是一项前瞻性研究,研究对象是因脓毒性休克入住 PICU(2021 年 6 月至 12 月)的儿童(1 个月至 18 岁)。研究收集了儿童的人口统计学资料、临床资料和治疗方法。进行了差异基因表达分析,以了解影响不同受试者的基因和通路:共招募了 15 名患者(脓毒性休克幸存者(5 人)、非幸存者(5 人)和非脓毒性休克对照组(5 人))。幸存者和非幸存者的中位年龄分别为 15(13,24)个月和 180(180,184)个月。脓毒症幸存者与非脓毒症对照组相比,有 983 个基因上调,624 个基因下调,而脓毒症非幸存者(SNS)与非脓毒症对照组相比,有 1,854 个基因上调,1,761 个基因下调。此外,与脓毒症幸存者相比,脓毒症非幸存者中出现的脱调基因数量最少(383个上调基因和486个下调基因)。与幸存者相比,在SNS中发现上调的主要Reactome通路包括CD22介导的B细胞受体(BCR)调节、血浆中血红素的清除以及C4和C2激活剂的产生,而T细胞受体(TCR)信号转导、纤维蛋白凝块形成的共同通路以及第二信使分子的产生则被发现下调:与死亡相关的基因特征是小儿败血症有希望的诊断生物标志物:Lalitha AV, Vasudevan A, Moorthy M, Ramaswamy G. Profiling Molecular Changes of Host Response to Predict Outcome in Children with Septic Shock.Indian J Crit Care Med 2024;28(9):879-886.
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引用次数: 0
Role of Peripheral Parenteral Nutrition Composition on Clinical Outcomes in Patients Undergoing Gastrectomy or Colectomy: A Phase III Indian Clinical Trial. 外周肠外营养成分对胃切除术或结肠切除术患者临床疗效的影响:印度 III 期临床试验
IF 1.5 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-09-01 Epub Date: 2024-08-31 DOI: 10.5005/jp-journals-10071-24800
Amit Goyal, Anand Pathak, B S Madhu, Harshad Soni, Keyur Bhatt, Kvvn Raju, Murali K Voonna, Rakshit Shah, Chetna Shah, Dignesh Patel

Aims and background: Various types of parenteral nutritional products exist, each with specific formulations designed to meet the diverse nutritional needs of patient's post-abdominal surgery. Here, two different parenteral nutrition (PN) solutions BFLUID and NUTRIFLEX PERI are compared in terms of therapeutic efficacy and safety profile.

Materials and methods: A prospective, multi-center, randomized, parallel-group, non-inferiority Phase III clinical trial compared two PN solutions namely BFLUID (N = 78) and NUTRIFLEX PERI (N = 72) in 150 patients undergoing gastrectomy or colectomy. Primary endpoints included length of hospital stay while secondary endpoints included assessment and comparison of length of ICU/HDU stay, assessment of incidents of infections and mortality, change in blood levels of vitamin B1, change in nutritional parameters, thrombophlebitis, pain at the injection site, and recording of adverse events (AEs).

Results: There was no significant difference in terms of length of hospital stay, length of ICU/HDU stay as well as changes in nutritional parameters from baseline and change in blood levels of vitamin B1 from baseline. Both study groups exhibited comparability in terms of AEs, pain at the injection site, and the incidence of phlebitis. There was no significant difference in the number and severity of adverse events reported in both groups. Additionally, no signs of infection were observed in patients from either group.

Conclusion: The trial successfully demonstrated the non-inferiority of BFLUID to NUTRIFLEX PERI. Moreover, the results indicated that PN enriched with high levels of branched-chain amino acids (BCAAs), essential amino acids (EAAs), and thiamine is both safe and efficacious for adult patients undergoing gastrectomy or colectomy.

How to cite this article: Goyal A, Pathak A, BS Madhu, Soni H, Bhatt K, Raju KVVN, et al. Role of Peripheral Parenteral Nutrition Composition on Clinical Outcomes in Patients Undergoing Gastrectomy or Colectomy: A Phase III Indian Clinical Trial. Indian J Crit Care Med 2024;28(9):871-878.

目的和背景:目前有多种肠外营养产品,每种产品都有特定的配方,旨在满足腹部手术后患者的不同营养需求。在此,我们对两种不同的肠外营养(PN)溶液 BFLUID 和 NUTRIFLEX PERI 的疗效和安全性进行了比较:一项前瞻性、多中心、随机、平行组、非劣效性 III 期临床试验比较了两种 PN 溶液,即 BFLUID(78 例)和 NUTRIFLEX PERI(72 例),对象是 150 名接受胃切除术或结肠切除术的患者。主要终点包括住院时间,次要终点包括ICU/HDU住院时间的评估和比较、感染和死亡事件的评估、血液中维生素B1水平的变化、营养参数的变化、血栓性静脉炎、注射部位疼痛以及不良事件(AEs)的记录:结果:两组在住院时间、重症监护室/重症加护病房住院时间、营养指标与基线相比的变化以及血液中维生素 B1 含量与基线相比的变化方面均无明显差异。两组研究在不良反应、注射部位疼痛和静脉炎发生率方面具有可比性。两组报告的不良事件在数量和严重程度上没有明显差异。此外,两组患者均未发现感染迹象:该试验成功证明了 BFLUID 不劣于 NUTRIFLEX PERI。此外,试验结果表明,富含高水平支链氨基酸(BCAAs)、必需氨基酸(EAAs)和硫胺素的 PN 对于接受胃切除术或结肠切除术的成年患者既安全又有效:Goyal A, Pathak A, BS Madhu, Soni H, Bhatt K, Raju KVVN, et al. Role of Peripheral Parenteral Nutrition Composition on Clinical Outcomes in Patients Undergoing Gastrectomy or Colectomy:印度 III 期临床试验。Indian J Crit Care Med 2024;28(9):871-878.
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Indian Journal of Critical Care Medicine
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