Status:

COMPLETED

Terlipressin in Combined Hepatorenal Syndrome in Patients With Signs of Chronic Renal Disease

Lead Sponsor:

University Hospital Freiburg

Collaborating Sponsors:

Jena University Hospital

Johannes Gutenberg University Mainz

Conditions:

Liver Cirrhosis

Hepato-Renal Syndrome

Eligibility:

All Genders

18+ years

Brief Summary

The aim of this retrospective study is to evaluate the treatment response to terlipressin and albumin in patients with suspicion of HRS-AKI and signs of chronic parenchymal kidney disease (HRS-AKI-lik...

Detailed Description

Liver cirrhosis is a major cause of global health burden, accounting for 31 million disability adjusted life years and 1 million deaths worldwide in 2010. In the natural history of liver disease, ther...

Eligibility Criteria

Inclusion

  • Patients with cirrhosis confirmed by histology or liver stiffness or with unequivocal signs in ultrasound, endoscopy and/or blood tests hospitalized between 1st of January 2018 and 31st of December 2022.
  • Evidence of ascites due to portal hypertension
  • Clinical suspicion of HRS-AKI or HRS-AKI-like syndrome (in case of previously diagnosed CKD)
  • Pre-existing data on kidney function (SCr and eGFR) minimum 3 months prior to admission in a stable situation
  • Dip stick urine test results (screening for proteinuria and hematuria) before initiation of AKI-treatment
  • Vasoactive treatment for the management of HRS-AKI, as defined by the administration of terlipressin or noradrenalin plus albumin
  • Age ≥ 18 years old

Exclusion

  • Uncontrolled shock
  • Patients with cardiac cirrhosis as defined by the development of cirrhosis in a patient with chronic heart failure due to a primary cardiac disease (ischemic cardiomyopathy, hypertensive cardiomyopathy, etc.)
  • Patients with hepatocellular carcinoma BCLC C or D
  • Patients receiving renal replacement therapy at baseline

Key Trial Info

Start Date :

March 3 2024

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2024

Estimated Enrollment :

490 Patients enrolled

Trial Details

Trial ID

NCT06161766

Start Date

March 3 2024

End Date

December 31 2024

Last Update

December 5 2025

Active Locations (4)

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Page 1 of 1 (4 locations)

1

University Medical Center Freiburg

Freiburg im Breisgau, Germany

2

University Medical center Jena

Jena, Germany

3

University Medical Center Mainz

Mainz, Germany

4

University Hospital Münster

Münster, Germany