Current partner codePEPTIDESDE
NCT03483272·Not applicable·OBSERVATIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

11

Locations

2

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Mar 30, 2018

  2. Study start

    Jan 8, 2018

  3. Primary completion

    Apr 15, 2021

  4. Study completion

    Apr 21, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Aug 16, 2021

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 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 outcomes

Flow changes (mL/min) in HRS-AKI patients with terlipressin non-response vs. response.

Time frame · 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.

Time frame · 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

Who can take part.

Minimum age
18 Years
Maximum age
78 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

2 registered sites.

Denmark. Showing up to 24 locations stored in the fast local snapshot.

Hvidovre University Hospital

Hvidovre, Capital Region, Denmark

Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital

Hvidovre, Denmark

Related trials

More studies on Terlipressin.

Related PeptideStat pages

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