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

I

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)

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

Trial contacts and locations

1

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Central trial contact

Senior Resident

Data sourced from clinicaltrials.gov

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