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

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ClinicalTrials.gov Identifier: NCT03483272
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Flemming Bendtsen, Hvidovre University Hospital

Brief Summary:

HRS is divided into two types. A chronic kidney failure (HRS-2), which is predominantly related to end-stage disease and a more acute kidney failure (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 type 1 (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
Hepato-Renal Syndrome Portal Hypertension Acute Kidney Injury Liver Diseases Liver Cirrhoses Cirrhosis Cardiac Cirrhosis

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Study Type : Observational
Estimated Enrollment : 30 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 : January 8, 2018
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


  2. 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


Biospecimen Retention:   Samples Without DNA
Standard clinical blood tests and pertinent bioactive substances is measured in blood and urine


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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483272


Locations
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Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Capital Region, Denmark, 2650
Contact: Flemming Bendtsen, Professor    0045 38623273    flemming.bendtsen@regionh.dk   
Contact: Karen V Danielsen, Ph.D-student    0045 22439449    karen.vagner.danielsen.02@regionh.dk   
Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Flemming Bendtsen, Professor    38623273    flemming.bendtsen@regionh.dk   
Sponsors and Collaborators
Hvidovre University Hospital

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Responsible Party: Flemming Bendtsen, Professor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03483272     History of Changes
Other Study ID Numbers: 17001401
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Flemming Bendtsen, Hvidovre University Hospital:
Terlipressin
Pharmacological respons
Magnetic Resonance Imaging
Hemodynamic assessments
Echocardiography
Hepatorenal syndrome - acute kidney injury

Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Hypertension, Portal
Hepatorenal Syndrome
Acute Kidney Injury
Syndrome
Fibrosis
Disease
Pathologic Processes
Digestive System Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Terlipressin
Antihypertensive Agents
Vasoconstrictor Agents