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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

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)

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04030065
Enrollment
124
Registered
2019-07-23
Start date
2018-12-02
Completion date
2019-11-30
Last updated
2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

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.

Interventions

DRUGOmega 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.

Sponsors

Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Early Allograft DysfunctionPost operative day 7To 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)

Secondary

MeasureTime frameDescription
Liver function test - trendTill period of hospital stay, average of 1 monthTo study the correlation between supplementation of omega-3 fatty acids and trend in post-operative LFTs
ComplicationsTill period of hospital stay, average of 1 monthPost-operative complications
ICU and hospital stayTill period of hospital stay, average of 1 monthTo determine the total hospital stay and ICU stay

Countries

India

Contacts

Primary ContactSenior Resident
vvkhere@gmail.com+918800984217

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026