MRI to Assess the Effect of Terlipressin in Patients With Acute Hepatorenal Syndrome (HRS-AKI)

Acute Kidney Injury Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483272
• Other study ID #: 17001401
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: April 21, 2021

Study information

• Verified date: August 2021
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 21, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• Patients with cirrhosis and acute hepatorenal syndrome (HRS-AKI)

• Patient of more than 18 and less than 78 years of age

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cirrhosis
• Cirrhosis Cardiac
• Fibrosis
• Hepato-Renal Syndrome
• Hepatorenal Syndrome
• Hypertension, Portal
• Liver Cirrhoses
• Liver Cirrhosis
• Liver Diseases
• Portal Hypertension
• Syndrome

Locations

Country	Name	City	State
Denmark	Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital	Hvidovre
Denmark	Hvidovre University Hospital	Hvidovre	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow (mL/min) in kidney and splanchnic vessels in patients with HRS-AKI and cirrhotic patients without kidney impairment	i) To characterize and compare changes in flow with MR and ECHO in patients with HRS-AKI compared to cirrhotic patients without kidney impairment	Baseline (mL/min)
Secondary	Flow changes (mL/min) in HRS-AKI patients with terlipressin non-response vs. response.	To investigate whether flow changes measured with MR and echocardiography induced by a single dose of terlipressin can predict the clinical (7 days) response to terlipressin treatment.; Full terlipressin response is if creatinine level returns to baseline after 7 days treatment.; Partial response is a reduction in creatinine of 25% after 7 days terlipressin treatment	Response after 7 days treatment (mL/min)
Secondary	Flow changes (mL/min) after terlipressin administration compared to mortality.	To investigate whether flow changes measured with MR and echocardiography induced by a single dose of terlipressin can predict the mortality after 90 days	90 days