Impact of Pretreatment With Omega 3 Enriched Lipid Emulsion on Early Neurological Complications After Living Donor Liver Transplantation. A Randomized Controlled Trial>
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- post-transplant neurological complications
研究概览
简要总结
To study the impact of pretreatment of living donor liver transplantation recipients with SMOF lipid on the incidence and severity of post-transplantation neurological complications in patients receiving tacrolimus based immunosuppression protocol
详细描述
All patients included in the study will receive the same immuno-suppression protocol based on tacrolimus and mycophenolate mofetil after the induction immuno-suppression during the intra-operative period.
Patients will have a full history taking and full neurological examination 48 hours prior to the designated operative date as a basal record.
the control group will not receive any lipid infusions at all the treatment group will receive the study emulsion (SMOF lipid 20% - Fresenius Kabi) starting 48 hours before the planned surgery day and will continue to receive it for 5 post-operative days by intravenous infusion.
During the post-operative period. patients will be assessed daily by full neurological examination as will as patient complaints (symptoms) related to neurological status for diagnosis of any neurological conditions (complications) that might arise during the study period.
Data will be analysed compared to the basal value in each group and between both control and intervention groups using the appropriate statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Adult living donor liver transplant recipients of either sex
排除标准
- •MELD score > 30
- •Retransplantation
- •Budd Chiari syndrome
- •Diabetes more than 10 years
研究组 & 干预措施
SMOF Group
Intervention Group: Patients receive 1 gm.kg.day-1 SMOFlipid for 48 hours before the operation and 5 days post-operatively.
干预措施: SMOF lipid (SMOFLIPID) pre treatment (Drug)
结局指标
主要结局
post-transplant neurological complications
时间窗: 5 post-operative days
Number of participants who develop neurological complications
次要结局
- survival(30 days)
- Graft functions(5 post-operative days)
研究者
Amr Mohamed Yassen
Professor of Anesthesia and Intensive care
Mansoura University