NCT04585672Unknown不适用
Ammonia Metabolism Assessed by Ammonia Infusion
Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年8月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Rate of clearance (L/min) and production (micromol/min) of ammonia
研究概览
简要总结
The present study will develop a method to assess ammonia metabolism by ammonia infusion and investigate ammonia production and clearance in healthy individuals and in patients with liver cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy controls:
- •Alcohol < 40g/day
- •BMI < 30
- •Diseased or medicated
- •Inclusion Criteria - Patients with cirrhosis:
- •Child-Pugh A or B cirrhosis
- •BMI < 30
排除标准
- •Child-Pugh score C
- •Kidney failure (eGFR < 60 mL/min/1.73m2)
- •Overt hepatic encephalopathy or more than one previous 1 episode of overt hepatic encephalopathy
- •Acute bacterial infection
- •Ammonia-targeted treatment of hepatic encephalopathy other than lactulose (including Rifaximin and branched-chain amino acids)
结局指标
主要结局
Rate of clearance (L/min) and production (micromol/min) of ammonia
时间窗: 2 years
A physiological parameter
次要结局
- Change in clearance (L/min) and production (micromol/min) of ammonia when measured while on ammonia modulating agents(2 years)
研究者
研究点 (2)
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