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

NCT03483272 | Completed

• 1 other identifier: 17001401
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Response after 7 days treatment (mL/min)

• Flow changes (mL/min) after terlipressin administration compared to mortality.

  90 days

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with cirrhosis and acute hepatorenal syndrome (HRS-AKI)
• Patient of more than 18 and less than 78 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (2)

Hvidovre University Hospital

Hvidovre, Capital Region, 2650, Denmark

Location

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

Hvidovre, 2650, Denmark

Location

Related Publications (1)

• Danielsen KV, Hove JD, Nabilou P, Kronborg TM, Wiese S, Siebner HR, Scott R, Francis ST, Aithal GP, Moller S, Bendtsen F. Mapping the hemodynamic effects of terlipressin in patients with hepatorenal syndrome using advanced magnetic resonance imaging. JHEP Rep. 2025 May 10;7(8):101452. doi: 10.1016/j.jhepr.2025.101452. eCollection 2025 Aug.

  PMID: 40677691 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Standard clinical blood tests and pertinent bioactive substances is measured in blood and urine

MeSH Terms

Conditions

Hepatorenal Syndrome; Hypertension, Portal; Acute Kidney Injury; Liver Diseases; Fibrosis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Flemming Bendtsen

  Hvidovre University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 30, 2018
• Study Start: January 8, 2018
• Primary Completion: April 15, 2021
• Study Completion: April 21, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

DK (2)