HRS-AKI Treatment With TIPS in Patients With Cirrhosis (NCT05346393) | Clinical Trial Compass
RecruitingNot Applicable
HRS-AKI Treatment With TIPS in Patients With Cirrhosis
Germany124 participantsStarted 2022-11-29
Plain-language summary
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).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
✓. ECOG \< 4 prior to hospital admission
✓. Subject has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Ethics Committee (EC) approved consent form.
✓. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses). A contraceptive method with a pearl index below 1% is assumed to be effective.
Exclusion criteria
✕. 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.
✕. Patients with cardiac cirrhosis as defined by the development of cirrhosis in a patient with chronic heart failure due to a primary cardiac disease (is-chemic cardiomyopathy, hypertensive cardiomyopathy, etc.)