Omega 3 Lipid Emulsions and Liver Transplantation

Not Applicable

• Conditions: Ischemia Re-perfusion Injury
• Interventions: Dietary Supplement: SMOFLipid; Dietary Supplement: equivalent volume of 10% glucose solution

• Registration Number: NCT01957943
• Lead Sponsor: Mansoura University

Brief Summary

The study Aims to investigate the possible beneficial impact of peri-operative or post-operative administration of Omega 3 enriched lipid emulsions on recipients for living donor liver transplantation.

Detailed Description

Patients will be divided intro three groups, A control group will receive equivalent volume of glucose 10% solution both 3 days before and 5 days after the operation .

A peri-operative groups, in which patients will receive omega 3 enriched lipid emulsion (SMOFLipid) for 2 days pre-transplantation and 5 days post-transplantation A Post-operative group, in which patients will receive glucose 10% 3 days before the operation and omega 3 enriched lipid emulsion (SMOFLipid) for 5 days post-transplantation The primary outcome objective will be the incidence of Ischemia re-perfusion injury, secondary outcomes includes post-operative complications, graft and patient's outcomes and graft regeneration

Study Timeline

• Study First Submitted: 2013-10-04
• Study First Submitted QC: 2013-10-04
• Study First Posted: 2013-10-08
• Study Start: 2014-05
• Status Verified: 2016-07
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28
• Primary Completion: 2017-12
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• All liver transplant recipients

Exclusion Criteria

• Budd chiari
• Previous upper abdominal surgery
• Re-transplantation
• Known allergy to the study emulsion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMEGA_POST	SMOFLipid	38 patients Will receive standard oral diet 3 days before the operation will receive glucose 10% solution 2 days before the operation Will receive omega 3 enriched lipid emulsion (SMOFlipid 20%) supplementation for 5 days postoperatively
Control	equivalent volume of 10% glucose solution	38 patients Will receive standard oral diet 3 days before the operation will receive similar volume of 10% glucose solution Will receive same solution for 5 days postoperatively
OMEGA_PRE	SMOFLipid	38 patients Will receive standard oral diet 3 days before the operation will receive lipid supplementation 2 days before the operation with omega 3 enriched lipid emulsion (SMOFlipid) Will receive omega 3 enriched lipid emulsion (SMOFlipid) supplementation for 5 days postoperatively

Primary Outcome Measures

Name	Time	Method
Ischemia reperfusion injury	5 days

Secondary Outcome Measures

Name	Time	Method
Liver functions	5 days
Late graft regeneration	3 month	assessment of percent of liver regeneration 13 months PO
Early graft regeneration	one month	assessment of percent of liver regeneration 1 month PO

Trial Locations

Locations (1)

Liver transplantation program - Gastroenterology surgical center - Mansoura university; 🇪🇬 Mansoura, Dakahlia, Egypt