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临床试验/NCT03483272
NCT03483272已完成不适用

MR-flow to Validate Hemodynamic Effect of Terlipressin in Patients With Acute Hepatorenal Syndrome: Can MRI and Echocardiography Predict the Pharmacological Response and Longterm Effect of Terlipressin?

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Flow (mL/min) in kidney and splanchnic vessels in patients with HRS-AKI and cirrhotic patients without kidney impairment

研究概览

简要总结

Heptorenal syndrome (HRS) is divided into two types. A non-acute kidney injury (NAKI-HRS), which is predominantly related to end-stage disease and a more acute kidney injury (HRS-AKI). HRS-AKI is potentially reversible and develops subsequent to aggravation of a systemic circulatory vasodilatation, that triggers renal vasoconstriction and deteriorates renal perfusion and function. The albumin and terlipressin response is evaluated clinically, routinely for a week and reduces mortality with 23% compared to no treatment. Only 40-50% of the patients with HRS-AKI respond to the treatment with terlipressin.

The treatment of hepatorenal syndrome (HRS-AKI) is aimed at improving blood flow to the kidneys. Flow changes associated to development of HRS have only sparsely been studied and not previously by MR technique and no previous studies have evaluated changes in flow induced by terlipressin. It has been hypothesized that development of HRS is associated to a deterioration in heart function with development of cardiomyopathy, which together with renal vasoconstriction leads to renal failure. Simultaneous MR-assessments of cardiac function and flows (especially the renal flow) in HRS-AKI have not previously been performed.

The aim of the project is to develop new, fast and non-invasive methods to evaluate hemodynamic changes and individual pharmacological terlipressin response in patients with acute hepatorenal syndrome (type HRS-AKI)

We expect a higher increase in renal blood flow in terlipressin-responders compared to terlipressin-non-responders and non-responders will generally have a lower basic renal flow and a decreased cardiac output.

Study design and patients The study design is experimental and includes 30 cirrhotic patients with HRS-AKI. Patients with HRS-AKI are MR scanned before and 17 minutes after their first dose of terlipressin. ECHO is performed before first dose of Terlipressin and is repeated after one of the first doses of terlipressin. Clinically efficacy is defined in accordance to international guidelines at day-7 and 90 days mortality is registered. The screening period and treatments follow international and national guidelines for acute renal failure in patients with cirrhosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with cirrhosis and acute hepatorenal syndrome (HRS-AKI)
  • Patient of more than 18 and less than 78 years of age

排除标准

  • Patients who are unable to give informed consent
  • Patients with absolute contraindication for MRI
  • Patients with absolute contraindication for terlipressin
  • Pregnant women
  • Patient with severe hemodynamic comorbidity

结局指标

主要结局

Flow (mL/min) in kidney and splanchnic vessels in patients with HRS-AKI and cirrhotic patients without kidney impairment

时间窗: Baseline (mL/min)

i) To characterize and compare changes in flow with MR and ECHO in patients with HRS-AKI compared to cirrhotic patients without kidney impairment

次要结局

  • Flow changes (mL/min) in HRS-AKI patients with terlipressin non-response vs. response.(Response after 7 days treatment (mL/min))
  • Flow changes (mL/min) after terlipressin administration compared to mortality.(90 days)

研究者

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

Flemming Bendtsen

Professor

Hvidovre University Hospital

研究点 (2)

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