Clinical trial NCT03483272: MRI to Assess the Effect of Terlipressin in Patients With Acute Hepatorenal Syndrome (HRS-AKI)
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?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepato-Renal Syndrome
Portal Hypertension
Acute Kidney Injury
Liver Diseases
Liver Cirrhoses
Cirrhosis Cardiac
Cirrhosis
Keywords: Terlipressin
Pharmacological respons
Magnetic Resonance Imaging
Hemodynamic assessments
Echocardiography
Hepatorenal syndrome - acute kidney injury
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 patients with cirrhosis and acute kidney injury who meet the criteria for HRS-AKI and needs terlipressin treatment.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Flow (mL/min) in kidney and splanchnic vessels in patients with HRS-AKI and cirrhotic patients without kidney impairment
timeFrame: Baseline (mL/min)
Secondary outcomes:
measure: Flow changes (mL/min) in HRS-AKI patients with terlipressin non-response vs. response.
timeFrame: Response after 7 days treatment (mL/min)
measure: Flow changes (mL/min) after terlipressin administration compared to mortality.
timeFrame: 90 days
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Capital Region
city: Hvidovre
country: Denmark
facility: Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Flemming Bendtsen
role: STUDY_CHAIR
References: