Omega 3 Lipid Emulsions and Liver Transplantation (OTLT)

March 24, 2017 updated by: Amr Mohamed Yassen, Mansoura University

Impact of Pre-treatment of Living-donor Liver Transplant Recipients With Omega 3 Enriched Lipid Emulsions on Graft and Patient Outcome. A Prospective, Randomized, Multi-central Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35511
        • Recruiting
        • Liver transplantation program - Gastroenterology surgical center - Mansoura university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All liver transplant recipients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
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
Dietary supplement: equivalent volume of 10% glucose solution
Patients will receive same dose of 10% glucose solution for 2 days pre operatives and 5 days post-operative
Other Names:
  • control group
Active Comparator: OMEGA_PRE
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
Dietary supplement: SMOFLipid
Other Names:
  • Omega 3 lipid emulsions
Active Comparator: OMEGA_POST
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
Dietary supplement: SMOFLipid
Other Names:
  • Omega 3 lipid emulsions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ischemia reperfusion injury
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver functions
Time Frame: 5 days
5 days
Early graft regeneration
Time Frame: one month
assessment of percent of liver regeneration 1 month PO
one month
Late graft regeneration
Time Frame: 3 month
assessment of percent of liver regeneration 13 months PO
3 month

Other Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: 28 days
28 days
length of hospital stay
Time Frame: 30 days
30 days
Renal functions
Time Frame: 28 days
28 days
Infection
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Amr M Yassen, MD, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

October 4, 2013

First Submitted That Met QC Criteria

October 4, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTX_SMOF_PRE_Eg

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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