跳至主要内容
临床试验/CTRI/2019/01/016915
CTRI/2019/01/016915招募中不适用

Randomized controlled trial to study the effect of intravenous supplementation of Omega-3 fatty acids on outcome of recipients in Living Donor Liver Transplantation (LDLT)

Institute of liver and biliary sciences1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2019年4月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
124
试验地点
1
主要终点
To study the effect of omega-3 fatty acids supplementation on recipients in LDLT and correlation with early allograft dysfunction

研究概览

简要总结

In this study, we aim to analyse the effect of Omega 3 fatty acid supplementation on recipients undergoing LDLT. In Group A, we are going to supplement Omega 3 fatty acid on preoperative day 1, intraoperatively and up to day 5 post operatively. We will analyse the effect of omega 3 fatty acid supplementation on early allograft dysfunction, its correlation with occurrence of postoperative complications. Group B, will be will constitute the controls for the study and hence attempt to find out the effect of omega 3 fatty acid supplementation on outcome of recipients of LDLT. We will analyse the data and elucidate the value of omega 3 fatty acid supplementation in reducing the occurrence of early allograft dysfunction , complications and effect on liver regeneration in recipients of LDLT.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All elective liver transplant recipients Adult patients Those who consent.

排除标准

  • Liver transplantation for fulminant hepatic failure Re-transplantation Known allergy to the study emulsion.

结局指标

主要结局

To study the effect of omega-3 fatty acids supplementation on recipients in LDLT and correlation with early allograft dysfunction

时间窗: Post operative day 7

次要结局

  • To study the effect of Omega-3 fatty acids supplementation on liver regeneration by CT volumetry(Post operative day 7)
  • To study the correlation between supplementation of omega-3 fatty acids and trend in post-operative LFTs(Till discharge)
  • Duration of hospital stay(Till discharge)
  • Post-operative complications(Till discharge)
  • Duration of ICU stay(Till discharge)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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