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

NCT04030065 | Unknown Phase 2

• 1 other identifier: ILBS-livertransplant-01
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Early Allograft Dysfunction

  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)

  Post operative day 7

Secondary Outcomes (3)

• Liver function test - trend

  Till period of hospital stay, average of 1 month

• Complications

  Till period of hospital stay, average of 1 month

• ICU and hospital stay

  Till period of hospital stay, average of 1 month

Study Arms (2)

Experimental Arm - omega 3 fatty acid

EXPERIMENTAL

Drug: Omega 3 fatty acid

Control Arm - No intervention

NO INTERVENTION

Interventions

Omega 3 fatty acid DRUG

10% Omega-3 fatty acid oil will be supplemented in intravenous form from preoperative day 1, intra-operatively (anytime during surgery before reperfusion of graft) and from post operative day 1 to day 5 in the study group. The preparation used will be 100 ml injection which contains 10 gm of Omega 3 fatty acids.

Experimental Arm - omega 3 fatty acid

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and biliary Sciences

New Delhi, 110070, India

RECRUITING

MeSH Terms

Interventions

Fatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Viniyendra Pamecha, Professor

  Professor and head , Department of HPB surgery and liver Transplantation, ILBS, New Delhi

  STUDY CHAIR

Central Study Contacts

Senior Resident

CONTACT

+918800984217; vvkhere@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident, Department of HPB surgery and Liver transplantation

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 23, 2019
• Study Start: December 2, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

IN (1)