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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Münster, , Germany
Freiburg, , Germany
Mainz, , Germany
Jena, , Germany
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