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临床试验/NCT04522297
NCT04522297已完成不适用

Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Acute Kidney Injury

National Hepatology & Tropical Medicine Research Institute1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2018年4月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Full response

研究概览

简要总结

Hepatorenal syndrome is a functional renal impairment occurring in cirrhotic patients . It develops secondary to splanchnic arterial vasodilatation which decreases the effective blood volume, activate the renin-angiotensin-aldosterone system, and stimulate of sympathetic nervous system.This study aims to compare the efficacy of nor-epinephrine versus midodrine/ octreotide, together with intravenous albumin on renal functions of patients with hepatorenal acute kidney injury.

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
None

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

入选标准

  • Both sexes aged 18 years or older having cirrhosis, ascites, and a diagnosis of HRS-AKI based on the 2015 International Club of Ascites (ICA) diagnostic criteria

排除标准

  • Serum creatinine (sCr) >7 mg/dL Hypotension (mean arterial pressure (MAP) <70 mm Hg) or sepsis. Recent treatment with vasopressors. Patients with severe cardiovascular disease Known allergy to study medications

研究组 & 干预措施

Midodrine/Octreotide

Experimental

oral midodrine plus octreotide as subcutaneous injection

干预措施: Midodrine/Octreotide (Drug)

Nor-epinephrine

Active Comparator

Intravenous infusion norepinephrine

干预措施: Nor-epinephrine (Drug)

结局指标

主要结局

Full response

时间窗: 10 days

the proportion of patients achieved full response defined as return of serum creatinine to a value within 0.3 mg/dl of the baseline value

次要结局

  • Partial response(10 days)
  • Reversal(10 days)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Doaa abdelaziz

Lecturer of clinical pharmacy

National Hepatology & Tropical Medicine Research Institute

研究点 (1)

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