Lipids and Neurological Complications in Liver Transplantation (LNCLT)

March 24, 2017 updated by: Amr Mohamed Yassen, Mansoura University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35511
        • Recruiting
        • Liver transplantation project - Gastroenterology surgical center - Mansoura university
        • Principal Investigator:
          • Amr M Yassen, MD
        • Sub-Investigator:
          • Mohamed Elmorshidy, MD
        • Sub-Investigator:
          • Elrefaiee Kandil, MD
        • Sub-Investigator:
          • Usama Elsaied, MD
        • Sub-Investigator:
          • Waleed R Elsarraf, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No Intervention group: Patients do not receive any lipid emulsion of any type during the study period
Active Comparator: SMOF Group
Intervention Group: Patients receive 1 gm.kg.day-1 SMOFlipid for 48 hours before the operation and 5 days post-operatively.
Drug: SMOF lipid (SMOFLIPID) pre treatment
Experimental Arm
Other Names:
  • Experimental group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Amr M Yassen, MD, Mansoura Faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 7, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMOF_NEURO_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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