---
title: Omega 3 Lipid Emulsions and Liver Transplantation
nct_id: NCT01957943
overall_status: UNKNOWN
phase: NA
sponsor: Mansoura University
study_type: INTERVENTIONAL
primary_condition: Ischemia Re-perfusion Injury
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01957943.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01957943"
ct_last_update_post_date: 2017-03-28
last_seen_at: "2026-05-12T06:46:31.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Omega 3 Lipid Emulsions and Liver Transplantation

**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.

**NCT ID:** [NCT01957943](https://clinicaltrials.gov/study/NCT01957943)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 114
- **Lead Sponsor:** Mansoura University
- **Conditions:** Ischemia Re-perfusion Injury
- **Start Date:** 2014-05
- **Completion Date:** 2018-03
- **CT.gov Last Update:** 2017-03-28

## 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

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* All liver transplant recipients

Exclusion Criteria:

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

## Arms

- **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
- **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
- **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

## Interventions

- **SMOFLipid** (DIETARY_SUPPLEMENT)
- **equivalent volume of 10% glucose solution** (DIETARY_SUPPLEMENT) — Patients will receive same dose of 10% glucose solution for 2 days pre operatives and 5 days post-operative

## Primary Outcomes

- **Ischemia reperfusion injury** _(time frame: 5 days)_

## Secondary Outcomes

- **Liver functions** _(time frame: 5 days)_
- **Early graft regeneration** _(time frame: one month)_
- **Late graft regeneration** _(time frame: 3 month)_

## Locations (1)

- Liver transplantation program - Gastroenterology surgical center - Mansoura university, Al Mansurah, Dakahlia Governorate, Egypt — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.liver transplantation program - gastroenterology surgical center - mansoura university|al mansurah|dakahlia governorate|egypt` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01957943.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01957943*  
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