Lipids and Neurological Complications in Liver Transplantation

Study Overview
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Brief Summary
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To study the impact of pretreatment of living donor liver transplantation recipients with SMOF lipid on the incidence and severity of post-transplantation neurological complications in patients receiving tacrolimus based immunosuppression protocol

Detailed Description
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All patients included in the study will receive the same immuno-suppression protocol based on tacrolimus and mycophenolate mofetil after the induction immuno-suppression during the intra-operative period. Patients will have a full history taking and full neurological examination 48 hours prior to the designated operative date as a basal record. the control group will not receive any lipid infusions at all the treatment group will receive the study emulsion (SMOF lipid 20% - Fresenius Kabi) starting 48 hours before the planned surgery day and will continue to receive it for 5 post-operative days by intravenous infusion. During the post-operative period. patients will be assessed daily by full neurological examination as will as patient complaints (symptoms) related to neurological status for diagnosis of any neurological conditions (complications) that might arise during the study period. Data will be analysed compared to the basal value in each group and between both control and intervention groups using the appropriate statistical tests.

Official Title
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Impact of Pretreatment With Omega 3 Enriched Lipid Emulsion on Early Neurological Complications After Living Donor Liver Transplantation. A Randomized Controlled Trial>

Conditions
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Neurological Complications

Intervention / Treatment
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* Drug: SMOF lipid (SMOFLIPID) pre treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult living donor liver transplant recipients of either sex Exclusion Criteria: MELD score > 30 Retransplantation Budd Chiari syndrome Diabetes more than 10 years

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No Intervention group: Patients do not receive any lipid emulsion of any type during the study period | |
| Active Comparator: SMOF Group<br>Intervention Group: Patients receive 1 gm.kg.day-1 SMOFlipid for 48 hours before the operation and 5 days post-operatively. | Drug: SMOF lipid (SMOFLIPID) pre treatment<br>* Experimental Arm<br>* Other names: Experimental group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-transplant neurological complications | Number of participants who develop neurological complications | 5 post-operative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft functions | the laboratory parameters for graft functions in both groups | 5 post-operative days | 
| survival | one month mortality | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMOF, neurological complications, neurotoxicity, liver transplantation, Lipid emulsions