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

Institute of Liver and Biliary Sciences, India

Status and phase: Unknown; Phase 2

Conditions: Liver Transplantation

Treatments: Drug: Omega 3 fatty acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04030065

ILBS-livertransplant-01

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Experimental Arm - omega 3 fatty acid

Experimental group

Treatment:

Drug: Omega 3 fatty acid

Control Arm - No intervention

No Intervention group