Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.
研究概览
简要总结
Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. We hypothesize that a combination of late evening and early morning protein supplement (Ensure Enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age
- •cirrhosis diagnosed by clinical history and liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis
- •at least 1 hospitalization for documented HE within the last 12 months.
- •abdominal CT scan anytime in the past
排除标准
- •Patients with MELD score > 35
- •end stage organ failure (major dysfunction requiring organ support)
- •kidney injury defined by a creatinine > 2 mg/dl or rise in creatinine by 0.5 gm/dl from baseline that is unresponsive to withholding diuretics and intravenous albumin administration (1 gm/kg up to 100 gm/day)
- •active malignancy
- •uncontrolled diabetes mellitus with A1c>9.5 (to avoid altered muscle protein metabolism
- •medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass
- •recent gastrointestinal surgery within past 12 months
- •ongoing infection (positive blood or other body fluid cultures)
- •active gastrointestinal bleeding.
结局指标
主要结局
Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.
时间窗: Day 0 & Day 180
Change in number of readmissions
次要结局
未报告次要终点
研究者
Srinivasan Dasarathy
Staff Physician
The Cleveland Clinic