Lipids and Neurological Complications in Liver Transplantation

NCT ID: NCT02544919

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Neurological Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

SMOF Group

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

Group Type ACTIVE_COMPARATOR

SMOF lipid (SMOFLIPID) pre treatment

Intervention Type DRUG

Experimental Arm

Interventions

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SMOF lipid (SMOFLIPID) pre treatment

Experimental Arm

Intervention Type DRUG

Other Intervention Names

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Experimental group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Amr Mohamed Yassen

Professor of Anesthesia and Intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr M Yassen, MD

Role: PRINCIPAL_INVESTIGATOR

MAnsoura Faculty of Medicine

Locations

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Liver transplantation project - Gastroenterology surgical center - Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr M. Yassen, MD

Role: CONTACT

01001497044 ext. +2

waleed R Elsarraf, MD

Role: CONTACT

Facility Contacts

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Amr M Yassen, MD

Role: primary

+201001497044

Waleed R Elsarraf, MD

Role: backup

+201222322727

Other Identifiers

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SMOF_NEURO_1

Identifier Type: -

Identifier Source: org_study_id

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