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Lipids and Neurological Complications in Liver Transplantation (LNCLT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02544919
Recruitment Status : Unknown
Verified July 2016 by Amr Mohamed Yassen, Mansoura University.
Recruitment status was:  Recruiting
First Posted : September 9, 2015
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Amr Mohamed Yassen, Mansoura University

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

Condition or disease Intervention/treatment Phase
Neurological Complications Drug: SMOF lipid (SMOFLIPID) pre treatment Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Pretreatment With Omega 3 Enriched Lipid Emulsion on Early Neurological Complications After Living Donor Liver Transplantation. A Randomized Controlled Trial>
Actual Study Start Date : September 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: SMOFlipid

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 Name: Experimental group




Primary Outcome Measures :
  1. post-transplant neurological complications [ Time Frame: 5 post-operative days ]
    Number of participants who develop neurological complications


Secondary Outcome Measures :
  1. Graft functions [ Time Frame: 5 post-operative days ]
    the laboratory parameters for graft functions in both groups

  2. survival [ Time Frame: 30 days ]
    one month mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544919


Contacts
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Contact: Amr M. Yassen, MD 01001497044 ext +2 amryassen@hotmail.com
Contact: waleed R Elsarraf, MD welsarraf@gmail.com

Locations
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Egypt
Liver transplantation project - Gastroenterology surgical center - Mansoura university Recruiting
Mansoura, Dakahlia, Egypt, 35511
Contact: Amr M Yassen, MD    +201001497044    amryassen@hotmail.com   
Contact: Waleed R Elsarraf, MD    +201222322727    welsarraf@gmail.com   
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         
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Amr M Yassen, MD MAnsoura Faculty of Medicine
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Responsible Party: Amr Mohamed Yassen, Professor of Anesthesia and Intensive care, Mansoura University
ClinicalTrials.gov Identifier: NCT02544919    
Other Study ID Numbers: SMOF_NEURO_1
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: July 2016
Keywords provided by Amr Mohamed Yassen, Mansoura University:
SMOF
neurological complications
neurotoxicity
liver transplantation
Lipid emulsions