NCT07634237尚未招募不适用
Personalized Nutritional Intervention to Prevent Overt Hepatic Encephalopathy in Patients With Cirrhosis and Refractory Ascites Who Undergo TIPS Insertion: A Multicenter Randomized Controlled Trial (SUPPRESS-HE Trial)
McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年6月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This study will evaluate whether a nutritional intervention is better than another to reduce the incidence of overt hepatic encephalopathy in patients undergoing TIPS insertion for refractory ascites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cirrhosis
- •TIPS planned for refractory ascites
- •Being at least moderately malnourished
排除标准
- •TIPS insertion for other reason than refractory ascites
- •Budd Chiari Syndrome
- •Complete or cavernomatous portal vein thrombosis
- •Pre-TIPS recurrent or persistent overt hepatic encephalopathy
- •Use of lactulose or rifaximin in the last 4 weeks
- •Liver failure (MELD > 18 or Child Pugh score > 12)
- •Heart failure (NYHA ≥ III or LVEF < 50%)
- •Kidney failure (serum creatinine > 250µmol/L)
- •Pregnancy or breastfeeding
- •Previous Liver transplantation
- •Unable to provide informed consent
研究者
Amine Benmassaoud
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
研究点 (1)
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