HRS-AKI Treatment With TIPS in Patients With Cirrhosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJena University Hospital
About this trial
The study compares the effectiveness and safety of TIPS implantation in patients with HRS-AKI (stage1, 2 and 3) and liver cirrhosis with standard therapy (drug therapy with terlipressin + albumin).
Eligibility criteria
Qualifiers
Patients with cirrhosis confirmed by histology or liver stiffness or with unequivocal signs in ultrasound, endoscopy and/or blood tests
Clinically evident ascites due to portal hypertension
HRS-AKI
Age: ≥ 18 to ≤ 80 years old at the time of consent
Disqualifiers
Recent or current use of nephrotoxic drugs (NSAIDS, Aminoglycosides or high-dosed iodinated contrast medium) in the previous 72 hours before AKI diagnosis
Improvement of renal function after 1 day of diuretic removal and plasma volume expansion with albumin 1-1.5 gr/kg
Uncontrolled shock within the last 48 hours prior to randomization
Patients with uncontrolled infection (defined by a 20 % increase in inflam-matory parameters (CRP, leucocytes or insufficient decrease of PMN in ascitic fluid < 25 % from baseline in the case of a SBP) despite 48 hours of antibiotic treatment.
Trial design
Treatments tested in this trial
- TIPS
- Standard of Care
Treatment groups
124 Participants
are divided into 2 treatment groupsLocations
14University Hospital RWTH Aachen52074, Aachen Germany
Charité - Universitätsmedizin Berlin CVK13353, Berlin Germany
University Hospital Dresden, Medical Clinic I, Gastroenterology01307, Dresden Germany
Universitätsklinikum Essen (AöR)45147, Essen Germany
Sponsors and collaborators
Jena University Hospital
Lead sponsor
German Research Foundation
Collaborator
University Hospital Halle (Saale)
Collaborator
Source ClinicalTrials.gov