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Search / Trial NCT06161766

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

Launched by UNIVERSITY HOSPITAL FREIBURG · Dec 7, 2023

Trial Information

Current as of May 20, 2025

Completed

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called terlipressin, along with albumin, in patients who have liver cirrhosis and signs of kidney problems. The main goal is to see how well this treatment works for patients suspected of having a specific type of kidney condition related to liver disease, particularly in those who may also have long-term kidney issues. The trial is currently looking for participants who are between 18 and 74 years old and have been hospitalized with liver cirrhosis and related kidney concerns.

To be eligible for this study, participants need to have a confirmed diagnosis of liver cirrhosis and evidence of fluid buildup in the abdomen. They should also have a history of kidney function tests from at least three months before being admitted to the hospital. However, some people won’t be able to join the trial, such as those in severe shock, those with a specific type of liver disease related to heart failure, or those already undergoing dialysis for kidney failure. Participants in the trial can expect to receive close monitoring and care while receiving the study treatment, helping researchers learn more about how to manage liver and kidney conditions effectively.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About University Hospital Freiburg

University Hospital Freiburg is a leading academic medical center in Germany, dedicated to advancing healthcare through innovative research and clinical trials. Affiliated with the University of Freiburg, the hospital integrates cutting-edge medical education, patient care, and scientific inquiry. Its commitment to excellence is reflected in its multidisciplinary approach, fostering collaboration among experts in various fields to develop and implement groundbreaking therapies. By participating in clinical trials, University Hospital Freiburg aims to enhance treatment options and improve patient outcomes, while contributing to the global body of medical knowledge.

Locations

Münster, , Germany

Freiburg, , Germany

Mainz, , Germany

Jena, , Germany

Patients applied

0 patients applied

Trial Officials

Cristina Ripoll, MD

Principal Investigator

University Hospital Jena

Dominik Bettinger, MD

Principal Investigator

University Hospital Freiburg

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported