临床试验/NCT01245257

NCT01245257已完成不适用

Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis

University of Aarhus1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2010年11月最近更新: 2016年9月12日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Aarhus
入组人数: 50
试验地点: 1
主要终点: Functional Hepatic Nitrogen Clearance

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with alcoholic hepatitis. The liver might play an important role in this stress-catabolism by increasing the production of urea during the inflammatory process.

The purpose of this study is to examine the regulation of urea synthesis in patients with alcoholic hepatitis and to study the effect of the anti-inflammatory drugs prednisolone and pentoxifylline on this regulation.

研究设计

研究类型: Observational
观察模型: Case Crossover
时间视角: Prospective

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

•Alcoholic hepatitis (alcohol intake (> 40g/day in 6 months), bilirubin > 80 μmol/l)

排除标准

•Severe bacterial infections
•Other chronical inflammatory diseases
•Other catabolic diseases
•Treatment with prednisolone or pentoxifylline within the last 8 weeks

结局指标

主要结局

Functional Hepatic Nitrogen Clearance

时间窗: At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment

次要结局

Clinical and biochemical measures of inflammation(At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment)

研究者

发起方

University of Aarhus

申办方类型

Other

责任方

Sponsor

研究点 (1)

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