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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Liver Transplantation
• Intervention / Treatment: Drug: Omega 3 fatty acid

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Senior Resident; Phone Number: +918800984217; Email: vvkhere@gmail.com

Study Locations

• India
  • New Delhi, India, 110070
    • Recruiting
    • Institute of liver and Biliary Sciences
    • Contact: Senior Resident

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Arm - omega 3 fatty acid	Drug: Omega 3 fatty acid; 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.
NO_INTERVENTION: Control Arm - No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Study Chair: Viniyendra Pamecha, Professor, Professor and head , Department of HPB surgery and liver Transplantation, ILBS, New Delhi

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2018
• Primary Completion (ANTICIPATED): November 30, 2019
• Study Completion (ANTICIPATED): November 30, 2019

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 21, 2019
• First Posted (ACTUAL): July 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 21, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ILBS-livertransplant-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No