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临床试验/CTRI/2024/07/071234
CTRI/2024/07/071234已完成不适用

Efficacy of albumin infusion for hypoalbuminemia in post operative period in living donor liver transplantation – An open label randomised controlled trial

Dr Subhash Gupta1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年8月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Primary Outcome is to determine if correcting hypoalbuminemia with albumin infusion in post LT period, helps in decreasing the surgical drain output by 20% on post operative day 5

研究概览

简要总结

Albumin’s role post-liver transplant is debated, with its use aimed at volume replacement and hemodynamic stability. Post-transplant hypoalbuminemia results from multiple factors like capillary leakage due to surgery-induced inflammation. Studies indicate increased albumin synthesis but decreased plasma levels, suggesting redistribution or altered degradation in the post-transplant period. Albumin infusion risks overhydration and volume overload. Previous studies have concluded that critically ill post-transplant patients gain no hemodynamic benefit from albumin over other fluids. Clinically, in our experience (high volume living donor liver transplant center) albumin hasn’t improved fluid management or inotropic support, leading instead to fluid overload, increased drain output, potential tacrolimus toxicity, and higher treatment costs. We planned this trial to assess the efficacy of albumin and rationalize the use of albumin therapy in the postoperative period of liver transplantation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Immediate post living donor liver transplant recipients (Aged greater than 18 years) admitted to the liver transplant intensive care unit.

排除标准

  • Pregnancy, 2)Age less than 18 years, 3)Re-transplantation, 4)Deceased donor LT, 5)Greater than 3 organ failure (ACLF grade 3), 6)Pre LT rapid filling ascites or Grade 3 ascites, 7)Primary graft failure, 8)Post LT vascular or biliary complication, 9)Negative consent, 10)Post LT correction of hypoalbuminemia (Sepsis, Hemodynamic instability, acute kidney injury), 11)Graft weight less than 600 grams, 12)Combined liver-kidney transplant.

结局指标

主要结局

Primary Outcome is to determine if correcting hypoalbuminemia with albumin infusion in post LT period, helps in decreasing the surgical drain output by 20% on post operative day 5

时间窗: Post Transplant Day 5

次要结局

  • To compare the incidence of serious adverse events till discharge(Discharge date)

研究者

发起方
Dr Subhash Gupta
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Subhash Gupta

Max Super Speciality Hospital, Saket, New Delhi

研究点 (1)

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