Lipids and Neurological Complications in Liver Transplantation

Phase 4

• Conditions: Neurological Complications
• Interventions: Drug: SMOF lipid (SMOFLIPID) pre treatment

• Registration Number: NCT02544919
• Lead Sponsor: Mansoura University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-07
• Study First Posted: 2015-09-09
• Status Verified: 2016-07
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-27
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMOF Group	SMOF lipid (SMOFLIPID) pre treatment	Intervention Group: Patients receive 1 gm.kg.day-1 SMOFlipid for 48 hours before the operation and 5 days post-operatively.

Primary Outcome Measures

Name	Time	Method
post-transplant neurological complications	5 post-operative days	Number of participants who develop neurological complications

Secondary Outcome Measures

Name	Time	Method
survival	30 days	one month mortality
Graft functions	5 post-operative days	the laboratory parameters for graft functions in both groups

Trial Locations

Locations (1)

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