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

Liver Transplantation Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04030065
• Other study ID #: ILBS-livertransplant-01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 2, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: July 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Senior Resident
• Phone: +918800984217
• Email: vvkhere[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

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.

Locations

Country	Name	City	State
India	Institute of liver and biliary Sciences	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Complications	Post-operative complications	Till period of hospital stay, average of 1 month
Secondary	ICU and hospital stay	To determine the total hospital stay and ICU stay	Till period of hospital stay, average of 1 month