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
NA
114 participants
INTERVENTIONAL
2014-05-31
2018-03-31
Brief Summary
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Detailed Description
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A peri-operative groups, in which patients will receive omega 3 enriched lipid emulsion (SMOFLipid) for 2 days pre-transplantation and 5 days post-transplantation A Post-operative group, in which patients will receive glucose 10% 3 days before the operation and omega 3 enriched lipid emulsion (SMOFLipid) for 5 days post-transplantation The primary outcome objective will be the incidence of Ischemia re-perfusion injury, secondary outcomes includes post-operative complications, graft and patient's outcomes and graft regeneration
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Control
38 patients Will receive standard oral diet 3 days before the operation will receive similar volume of 10% glucose solution Will receive same solution for 5 days postoperatively
equivalent volume of 10% glucose solution
Patients will receive same dose of 10% glucose solution for 2 days pre operatives and 5 days post-operative
OMEGA_PRE
38 patients Will receive standard oral diet 3 days before the operation will receive lipid supplementation 2 days before the operation with omega 3 enriched lipid emulsion (SMOFlipid) Will receive omega 3 enriched lipid emulsion (SMOFlipid) supplementation for 5 days postoperatively
SMOFLipid
OMEGA_POST
38 patients Will receive standard oral diet 3 days before the operation will receive glucose 10% solution 2 days before the operation Will receive omega 3 enriched lipid emulsion (SMOFlipid 20%) supplementation for 5 days postoperatively
SMOFLipid
Interventions
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SMOFLipid
equivalent volume of 10% glucose solution
Patients will receive same dose of 10% glucose solution for 2 days pre operatives and 5 days post-operative
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous upper abdominal surgery
* Re-transplantation
* Known allergy to the study emulsion
20 Years
60 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Amr Mohamed Yassen
Professor Doctor Amr M. Yassen
Principal Investigators
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Amr M Yassen, MD
Role: STUDY_CHAIR
Mansoura University
Locations
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Liver transplantation program - 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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LTX_SMOF_PRE_Eg
Identifier Type: -
Identifier Source: org_study_id
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