HRS-AKI Treatment With TIPS in Patients With Cirrhosis

Exclusion Criteria26

• 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.)
• 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 cavernous portal vein thrombosis, splenic vein thrombosis or mesenteric vein thrombosis
• Patients with clinically significant cardiac disease (NYHA ≥ II)
• Patients with diastolic dysfunction grade 3.
• Patients with a reduced systolic function with an ejection fraction ≤ 50 %
• Patients with ACLF grade 3
• Patients with creatinine value > 442 µmol/L (≙ 5 mg/dL)
• 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 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 who already had a liver transplantation
• Patients with other comorbidities that lead to an estimated life expectancy under 1 year.
• Patients with respiratory insufficiency which requires mechanical ventila-tion
• Patients with circulatory failure which requires administration of other vas-opressors (catecholamines)
• Patients receiving renal replacement therapy
• The subject is currently enrolled in another investigational device or drug trial.
• Patients with pregnancy or lactation
• Patients which are suspected to be incompliant for study participation.