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)
试验速览
- 阶段
- 2 期
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Early Allograft Dysfunction
研究概览
简要总结
In this study, the investigators aim to analyse the effect of Omega 3 fatty acid supplementation on recipients undergoing living donor liver transplantation. In Group A, the patients receive Omega 3 fatty acid on preoperative day 1, intraoperatively and up to day 5 post operatively; and the effect of omega 3 fatty acid supplementation on early allograft dysfunction, its correlation with occurrence of postoperative complications and liver regeneration measured by CT volumetry on Day 7. Group B, the patients are controls for the study and hence attempt to find out the effect of omega 3 fatty acid supplementation on outcome of recipients of Living donor liver transplantation. the investigators 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 Living donor liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
Experimental Arm - omega 3 fatty acid
干预措施: Omega 3 fatty acid (Drug)
结局指标
主要结局
Early Allograft Dysfunction
时间窗: Post operative day 7
To study the correlation with early allograft dysfunction using definition of early allograft dysfunction based on laboratory parameters (presence of one or more of the following : bilirubin \>or=10mg/dL on day 7, international normalized ratio \>or=1.6 on day 7, and alanine or aspartate aminotransferases \>2000 IU/L within the first 7 days)
次要结局
- ICU and hospital stay(Till period of hospital stay, average of 1 month)
- Liver function test - trend(Till period of hospital stay, average of 1 month)
- Complications(Till period of hospital stay, average of 1 month)
研究者
Vivek Rajendran
Senior Resident, Department of HPB surgery and Liver transplantation
Institute of Liver and Biliary Sciences, India