Lipids and Neurological Complications in Liver Transplantation
NCT ID: NCT02544919
Last Updated: 2017-03-27
Study Results
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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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2015-09-30
2017-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
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
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.
SMOF lipid (SMOFLIPID) pre treatment
Experimental Arm
Interventions
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SMOF lipid (SMOFLIPID) pre treatment
Experimental Arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Retransplantation
* Budd Chiari syndrome
* Diabetes more than 10 years
20 Years
60 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Amr Mohamed Yassen
Professor of Anesthesia and Intensive care
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SMOF_NEURO_1
Identifier Type: -
Identifier Source: org_study_id
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