NCT01957943

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 28, 2017

Status Verified

July 1, 2016

Enrollment Period

3.6 years

First QC Date

October 4, 2013

Last Update Submit

March 24, 2017

Conditions

Ischemia Re-perfusion Injury

Keywords

Omega 3 lipid emulsionsLiver transplantationIschemia reperfusion injurygraft function

Outcome Measures

Primary Outcomes (1)

  • Ischemia reperfusion injury

    5 days

Secondary Outcomes (3)

  • Liver functions

    5 days

  • Early graft regeneration

    one month

  • Late graft regeneration

    3 month

Other Outcomes (4)

  • mortality

    28 days

  • Renal functions

    28 days

  • Infection

    28 days

  • +1 more other outcomes

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Dietary Supplement: equivalent volume of 10% glucose solution

OMEGA_PRE

ACTIVE COMPARATOR

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

Dietary Supplement: SMOFLipid

OMEGA_POST

ACTIVE COMPARATOR

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

Dietary Supplement: SMOFLipid

Interventions

SMOFLipidDIETARY_SUPPLEMENT
Also known as: Omega 3 lipid emulsions
OMEGA_POSTOMEGA_PRE
equivalent volume of 10% glucose solutionDIETARY_SUPPLEMENT

Patients will receive same dose of 10% glucose solution for 2 days pre operatives and 5 days post-operative

Also known as: control group
Control

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All liver transplant recipients

You may not qualify if:

  • Budd chiari
  • Previous upper abdominal surgery
  • Re-transplantation
  • Known allergy to the study emulsion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver transplantation program - Gastroenterology surgical center - Mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Reperfusion Injury

Interventions

SMOFlipidControl Groups

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Amr M Yassen, MD

    Mansoura University

    STUDY CHAIR

Central Study Contacts

Amr M Yassen, Md

CONTACT

+201001497044amryassen@hotmail.com

Waleed R Elsarraf, MD

CONTACT

+201222322727welsarraf@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor Amr M. Yassen

Study Record Dates

First Submitted

October 4, 2013

First Posted

October 8, 2013

Study Start

May 1, 2014

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

March 28, 2017

Record last verified: 2016-07

Locations

EG(1)