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 groupsSponsors and collaborators
Jena University Hospital
Lead sponsor
German Research Foundation
Collaborator
University Hospital Halle (Saale)
Collaborator
Source ClinicalTrials.gov