NCT02544919

Lipids and Neurological Complications in Liver Transplantation

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurological Complications

Interventions

Type	Name	Description
DRUG	SMOF lipid (SMOFLIPID) pre treatment	Experimental Arm

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2015-09-09
• Last updated: 2017-03-27

Locations

1 site across 1 country: Egypt