Lipids and Neurological Complications in Liver Transplantation

Neurological Complications Clinical Trial

— LNCLT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02544919
• Other study ID #: SMOF_NEURO_1
• Status: Recruiting
• Phase: Phase 4
• First received: September 7, 2015
• Last updated: March 24, 2017
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Mansoura University
• Contact: Amr M. Yassen, MD
• Phone: 01001497044
• Email: amryassen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurological Complications

Intervention

Drug:
• SMOF lipid (SMOFLIPID) pre treatment
Experimental Arm

Locations

Country	Name	City	State
Egypt	Liver transplantation project - Gastroenterology surgical center - Mansoura university	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-transplant neurological complications	Number of participants who develop neurological complications	5 post-operative days
Secondary	Graft functions	the laboratory parameters for graft functions in both groups	5 post-operative days
Secondary	survival	one month mortality	30 days