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临床试验/CTRI/2024/09/074465
CTRI/2024/09/074465尚未招募不适用

Effect of positive cumulative fluid balance on post-operative complications in patients undergoing liver transplant for acute liver failure - A retrospective observational study

Institute of Liver and Biliary Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Length of ICU stay (in days)

研究概览

简要总结

Positive cumulative fluid balance (CFB) in patients undergoing surgery and in critically ill patients has been associated with increased morbidity and mortality. With respect to liver transplant (LT) surgery, there are periods of hemodynamic instability with significant blood loss, reperfusion phase-induced hypotension frequently requiring active resuscitation, and risk of systemic inflammatory response with endothelial leak and extravascular fluid shifts. CFB after LT puts patients at risk for several multi-organ system complications including prolonged intubation and oxygen requirement, interstitial edema with delayed wound healing, and bowel wall edema with impaired bowel function and prolonged receipt of IV fluids or parenteral nutrition, contributing to prolonged postoperative ICU and hospital length-of-stay. Intra-operative fluid management of patients undergoing LT for ALF differs from that of CLD due to the difference in etiology and absence of compensatory pathological changes present in CLD patients. Studies where the impact of positive cumulative fluid balance on post-operative outcomes after LT is studied, are mostly done on adult and pediatric patients who presented with end-stage liver disease. We aim to study the effect of pre-operative and intra-operative CFB, in patients (both adult and pediatric) undergoing LT for ALF, on post-operative outcomes. We will review records of all patients who underwent LT for ALF in the last 10 years at the ILBS and exclude the ones with incomplete records. We hypothesize that positive CFB in pre-operative and intra-operative periods leads to increased length of ICU stay and incidence of post-operative renal, pulmonary and neurological outcomes.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients who underwent liver transplant at the ILBS for acute liver failure from January 2014 to July 2024 will be included in the study.

排除标准

  • Patients with incomplete records.

结局指标

主要结局

Length of ICU stay (in days)

时间窗: At baseline (after shifting the patient to ICU after liver transplant surgery)

次要结局

  • Development of renal, pulmonary & neurological complications after liver transplant.
  • Number of days on mechanical ventilation

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Medhavi Saxena

Institute of Liver and Biliary Sciences, New Delhi

研究点 (1)

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