Omega 3 Lipid Emulsions and Liver Transplantation

Ischemia Re-perfusion Injury Clinical Trial

— OTLT  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01957943
• Other study ID #: LTX_SMOF_PRE_Eg
• Status: Recruiting
• Phase: N/A
• First received: October 4, 2013
• Last updated: March 24, 2017
• Start date: May 2014
• Est. completion date: March 2018

Study information

• Verified date: July 2016
• Source: Mansoura University
• Contact: Amr M Yassen, Md
• Phone: +201001497044
• Email: amryassen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• All liver transplant recipients

Exclusion Criteria:

• Budd chiari

• Previous upper abdominal surgery

• Re-transplantation

• Known allergy to the study emulsion

Related Conditions & MeSH terms

• Ischemia
• Ischemia Re-perfusion Injury
• Reperfusion Injury

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Egypt	Liver transplantation program - Gastroenterology surgical center - Mansoura university	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mortality		28 days
Other	Renal functions		28 days
Other	Infection		28 days
Other	length of hospital stay		30 days
Primary	Ischemia reperfusion injury		5 days
Secondary	Liver functions		5 days
Secondary	Early graft regeneration	assessment of percent of liver regeneration 1 month PO	one month
Secondary	Late graft regeneration	assessment of percent of liver regeneration 13 months PO	3 month