Omega 3 Lipid Emulsions and Liver Transplantation (OTLT)

Mansoura University

Status: Unknown

Conditions: Ischemia Re-perfusion Injury

Treatments: Dietary Supplement: equivalent volume of 10% glucose solution; Dietary Supplement: SMOFLipid

Study type: Interventional

Funder types: Other

Identifiers

NCT01957943

LTX_SMOF_PRE_Eg

Details and patient eligibility

About

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.

Full 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

Enrollment: 114 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All liver transplant recipients

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: equivalent volume of 10% glucose solution

OMEGA_PRE

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: SMOFLipid

OMEGA_POST

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: SMOFLipid