HRS-AKI Treatment With TIPS in Patients With Cirrhosis

Trial details

Who runs it

Jena University Hospital

Trial code

NCT05346393

Record updated

18 November 2024

Original description

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).Read full original descriptionShow less

Hepatorenal Syndrome-acute Kidney Injury (HRS-AKI) Treatment With Transjugular Intrahepatic Portosystemic Shunt in Patients With Cirrhosis. A Randomized Controlled 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).

Inclusion: 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: Recent or current use of nephrotoxic drugs (NSAIDS, Aminoglycosides or high-dosed iodinated contrast medium) in the previous 72 hours before AKI diagnosis; Uncontrolled shock within the last 48 hours prior to randomization; Patients who already had a liver transplantation; Patients receiving renal replacement therapy; The subject is currently enrolled in another investigational device or drug trial; 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.); Patients with cavernous portal vein thrombosis, splenic vein thrombosis or mesenteric vein thrombosis; Patients with clinically significant cardiac disease (NYHA ≥ II); Patients with an acute variceal bleeding at the time of screening who have indication for pre-emptive TIPS and/or terlipressin; Patients with refractory ascites as defined by the International Ascites Club (< 800 gr weight loss over 4 days in patients on low salt diet and high dose diuretics (spironolactone 400 mg /day and furosemide * 160 mg /day), or lower dose of diuretics with complications secondary to the use of diuretics such as hyponatremia, renal failure, hepatic encephalopathy. *equivalent dose of torasemide 40 mg/day; Patients with respiratory insufficiency which requires mechanical ventila-tion; Patients with circulatory failure which requires administration of other vas-opressors (catecholamines); Improvement of renal function after 1 day of diuretic removal and plasma volume expansion with albumin 1-1.5 gr/kg; Patients with contraindications to TIPS placement (e.g. Bilirubin > 85.5 µmol/L (≙ 5 mg/dL), recurrent hepatic encephalopathy, clinically relevant pulmonary hypertension, aortic stenosis); Patients with a reduced systolic function with an ejection fraction ≤ 50 %; Patients with creatinine value > 442 µmol/L (≙ 5 mg/dL); Patients with diastolic dysfunction grade 3; Patients with ACLF grade 3; Patients with hepatocellular carcinoma outside of the Milan criteria; Patients with hepatocellular carcinoma within the Milan criteria in whom the tumor is located in the puncture tract; Patients with benign liver tumors (except regenerative nodules) which are located in the puncture tract; Patients who already have a TIPS placed; Patients with other comorbidities that lead to an estimated life expectancy under 1 year; Patients with pregnancy or lactation; Patients which are suspected to be incompliant for study participation.

ClinicalTrials.gov NCT05346393