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.
试验速览
- 阶段
- 不适用
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Ischemia reperfusion injury
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All liver transplant recipients
排除标准
- •Budd chiari
- •Previous upper abdominal surgery
- •Re-transplantation
- •Known allergy to the study emulsion
研究组 & 干预措施
Control
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
干预措施: equivalent volume of 10% glucose solution (Dietary Supplement)
OMEGA_POST
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
干预措施: SMOFLipid (Dietary Supplement)
OMEGA_PRE
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
干预措施: SMOFLipid (Dietary Supplement)
结局指标
主要结局
Ischemia reperfusion injury
时间窗: 5 days
次要结局
- Liver functions(5 days)
- Late graft regeneration(3 month)
- Early graft regeneration(one month)
研究者
Amr Mohamed Yassen
Professor Doctor Amr M. Yassen
Mansoura University