Omega 3 Lipid Emulsions and Liver Transplantation

Impact of Pre-treatment of Living-donor Liver Transplant Recipients With Omega 3 Enriched Lipid Emulsions on Graft and Patient Outcome. A Prospective, Randomized, Multi-central Trial.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01957943

Acronym

OTLT

Enrollment

114

Registered

2013-10-08

Start date

2014-05-31

Completion date

2018-03-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia Re-perfusion Injury

Keywords

Omega 3 lipid emulsions, Liver transplantation, Ischemia reperfusion injury, graft function

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.

Detailed description

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

Interventions

DIETARY_SUPPLEMENTSMOFLipid

DIETARY_SUPPLEMENTequivalent volume of 10% glucose solution

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Inclusion criteria

* All liver transplant recipients

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Ischemia reperfusion injury	5 days

Secondary

Measure	Time frame	Description
Liver functions	5 days	—
Early graft regeneration	one month	assessment of percent of liver regeneration 1 month PO
Late graft regeneration	3 month	assessment of percent of liver regeneration 13 months PO

Other

Measure	Time frame
Infection	28 days
length of hospital stay	30 days
mortality	28 days
Renal functions	28 days

Countries

Egypt

Contacts

Primary ContactAmr M Yassen, Md

amryassen@hotmail.com+201001497044

Backup ContactWaleed R Elsarraf, MD

welsarraf@yahoo.com+201222322727

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026