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

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03483272

Collaborator

(none)

Enrollment

Locations

39.4

Actual Duration (Months)

5.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepato-Renal Syndrome Portal Hypertension Acute Kidney Injury Liver Diseases Liver Cirrhoses Cirrhosis Cardiac Cirrhosis

Study Design

Study Type:

Observational

Actual Enrollment :

11 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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?

Actual Study Start Date :

Jan 8, 2018

Actual Primary Completion Date :

Apr 15, 2021

Actual Study Completion Date :

Apr 21, 2021

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Flow changes (mL/min) in HRS-AKI patients with terlipressin non-response vs. response. [Response after 7 days treatment (mL/min)]
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
Flow changes (mL/min) after terlipressin administration compared to mortality. [90 days]
To investigate whether flow changes measured with MR and echocardiography induced by a single dose of terlipressin can predict the mortality after 90 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hvidovre University Hospital	Hvidovre	Capital Region	Denmark	2650
2	Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital	Hvidovre		Denmark	2650