Omega 3 Lipid Emulsions and Liver Transplantation

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Ischemia Re-perfusion Injury

Intervention / Treatment
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* Dietary Supplement: SMOFLipid
* Dietary Supplement: equivalent volume of 10% glucose solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All liver transplant recipients Exclusion Criteria: Budd chiari Previous upper abdominal surgery Re-transplantation Known allergy to the study emulsion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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<br>* Patients will receive same dose of 10% glucose solution for 2 days pre operatives and 5 days post-operative<br>* Other names: control group;|
| Active Comparator: OMEGA_PRE<br>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<br> <br> * Other names: Omega 3 lipid emulsions;|
| Active Comparator: OMEGA_POST<br>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<br> <br> * Other names: Omega 3 lipid emulsions;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia reperfusion injury |  | 5 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega 3 lipid emulsions, Liver transplantation, Ischemia reperfusion injury, graft function