Study to Assess the Effect of Intravenous Supplementation of Omega-3 Fatty Acids on Outcome of Recipients in Living Donor Liver Transplantation

Phase 2

• Conditions: Liver Transplantation
• Interventions: Drug: Omega 3 fatty acid

• Registration Number: NCT04030065
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-02
• Status Verified: 2019-07
• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-21
• Last Update Submitted: 2019-07-21
• Study First Posted: 2019-07-23
• Last Update Posted: 2019-07-23
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm - omega 3 fatty acid	Omega 3 fatty acid	-

Primary Outcome Measures

Name	Time	Method
Early Allograft Dysfunction	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 Outcome Measures

Name	Time	Method
ICU and hospital stay	Till period of hospital stay, average of 1 month	To determine the total hospital stay and ICU stay
Liver function test - trend	Till period of hospital stay, average of 1 month	To study the correlation between supplementation of omega-3 fatty acids and trend in post-operative LFTs
Complications	Till period of hospital stay, average of 1 month	Post-operative complications

Trial Locations

Locations (1)

Institute of liver and biliary Sciences; 🇮🇳 New Delhi, India