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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02544919

Acronym

LNCLT

Enrollment

Registered

2015-09-09

Start date

2015-09-30

Completion date

2017-12-31

Last updated

2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological Complications

Keywords

SMOF, neurological complications, neurotoxicity, liver transplantation, Lipid emulsions

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.

Interventions

DRUGSMOF lipid (SMOFLIPID) pre treatment

Experimental Arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Contacts

Primary ContactAmr M. Yassen, MD

amryassen@hotmail.com01001497044

Backup Contactwaleed R Elsarraf, MD

welsarraf@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026