Lipids and Neurological Complications in Liver Transplantation (LNCLT)

Mansoura University

Status and phase: Unknown; Phase 4

Conditions: Neurological Complications

Treatments: Drug: SMOF lipid (SMOFLIPID) pre treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02544919

SMOF_NEURO_1

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Control group

No Intervention group

Description:

No Intervention group: Patients do not receive any lipid emulsion of any type during the study period

SMOF Group

Active Comparator group

Description:

Intervention Group: Patients receive 1 gm.kg.day-1 SMOFlipid for 48 hours before the operation and 5 days post-operatively.

Treatment:

Drug: SMOF lipid (SMOFLIPID) pre treatment