Omega 3 Lipid Emulsions and Liver Transplantation

NCT ID: NCT01957943

Last Updated: 2017-03-28

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

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-03-31

Brief Summary

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The study Aims to investigate the possible beneficial impact of peri-operative or post-operative administration of Omega 3 enriched lipid emulsions on recipients for living donor liver transplantation.

Detailed Description

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Patients will be divided intro three groups, A control group will receive equivalent volume of glucose 10% solution both 3 days before and 5 days after the operation .

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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Ischemia Re-perfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

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

Group Type PLACEBO_COMPARATOR

equivalent volume of 10% glucose solution

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

SMOFLipid

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

SMOFLipid

Intervention Type DIETARY_SUPPLEMENT

Interventions

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SMOFLipid

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Omega 3 lipid emulsions control group

Eligibility Criteria

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Inclusion Criteria

* All liver transplant recipients

Exclusion Criteria

* Budd chiari
* Previous upper abdominal surgery
* Re-transplantation
* Known allergy to the study emulsion
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 Doctor Amr M. Yassen

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr M Yassen, Md

Role: CONTACT

+201001497044

Waleed R Elsarraf, MD

Role: CONTACT

+201222322727

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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LTX_SMOF_PRE_Eg

Identifier Type: -

Identifier Source: org_study_id

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