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)
Overview
- Phase
- Phase 2
- Intervention
- Omega 3 fatty acid
- Conditions
- Liver Transplantation
- Sponsor
- Institute of Liver and Biliary Sciences, India
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Early Allograft Dysfunction
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Vivek Rajendran
Senior Resident, Department of HPB surgery and Liver transplantation
Institute of Liver and Biliary Sciences, India
Eligibility Criteria
Inclusion Criteria
- •All elective liver transplant recipients
- •Adult patients
- •Those who consent
Exclusion Criteria
- •Liver transplantation for fulminant hepatic failure
- •Re-transplantation
- •Known allergy to the study emulsion
Arms & Interventions
Experimental Arm - omega 3 fatty acid
Intervention: Omega 3 fatty acid
Outcomes
Primary Outcomes
Early Allograft Dysfunction
Time Frame: 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)
Secondary Outcomes
- 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)