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Omega 3 Lipid Emulsions and Liver Transplantation (OTLT)

Primary Purpose

Ischemia Re-perfusion Injury

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
SMOFLipid
equivalent volume of 10% glucose solution
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ischemia Re-perfusion Injury focused on measuring Omega 3 lipid emulsions, Liver transplantation, Ischemia reperfusion injury, graft function

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All liver transplant recipients

Exclusion Criteria:

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

Sites / Locations

  • Liver transplantation program - Gastroenterology surgical center - Mansoura universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control

OMEGA_PRE

OMEGA_POST

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Ischemia reperfusion injury

Secondary Outcome Measures

Liver functions
Early graft regeneration
assessment of percent of liver regeneration 1 month PO
Late graft regeneration
assessment of percent of liver regeneration 13 months PO

Full Information

First Posted
October 4, 2013
Last Updated
March 24, 2017
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01957943
Brief Title
Omega 3 Lipid Emulsions and Liver Transplantation
Acronym
OTLT
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia Re-perfusion Injury
Keywords
Omega 3 lipid emulsions, Liver transplantation, Ischemia reperfusion injury, graft function

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
OMEGA_PRE
Arm Type
Active Comparator
Arm Description
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
Arm Title
OMEGA_POST
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
SMOFLipid
Other Intervention Name(s)
Omega 3 lipid emulsions
Intervention Type
Dietary Supplement
Intervention Name(s)
equivalent volume of 10% glucose solution
Other Intervention Name(s)
control group
Intervention Description
Patients will receive same dose of 10% glucose solution for 2 days pre operatives and 5 days post-operative
Primary Outcome Measure Information:
Title
Ischemia reperfusion injury
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Liver functions
Time Frame
5 days
Title
Early graft regeneration
Description
assessment of percent of liver regeneration 1 month PO
Time Frame
one month
Title
Late graft regeneration
Description
assessment of percent of liver regeneration 13 months PO
Time Frame
3 month
Other Pre-specified Outcome Measures:
Title
mortality
Time Frame
28 days
Title
Renal functions
Time Frame
28 days
Title
Infection
Time Frame
28 days
Title
length of hospital stay
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All liver transplant recipients Exclusion Criteria: Budd chiari Previous upper abdominal surgery Re-transplantation Known allergy to the study emulsion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr M Yassen, Md
Phone
+201001497044
Email
amryassen@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Waleed R Elsarraf, MD
Phone
+201222322727
Email
welsarraf@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr M Yassen, MD
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Liver transplantation program - Gastroenterology surgical center - Mansoura university
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr M Yassen, MD
Phone
+201001497044
Email
amryassen@hotmail.com
First Name & Middle Initial & Last Name & Degree
waleed R elsarraf, MD
Phone
+201222322727
Email
welsarraf@gmail.com

12. IPD Sharing Statement

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Omega 3 Lipid Emulsions and Liver Transplantation

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