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

NCT ID: NCT04030065

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-02

Study Completion Date

2019-11-30

Brief Summary

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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

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Conditions

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Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental Arm - omega 3 fatty acid

Group Type EXPERIMENTAL

Omega 3 fatty acid

Intervention Type 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.

Control Arm - No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Vivek Rajendran

Senior Resident, Department of HPB surgery and Liver transplantation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Viniyendra Pamecha, Professor

Role: STUDY_CHAIR

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

Locations

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Institute of liver and biliary Sciences

New Delhi, , India

Site Status RECRUITING

Countries

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India

Central Contacts

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Senior Resident

Role: CONTACT

+918800984217

Facility Contacts

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Senior Resident

Role: primary

Other Identifiers

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ILBS-livertransplant-01

Identifier Type: -

Identifier Source: org_study_id

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