HRS-AKI Treatment With TIPS in Patients With Cirrhosis

Inclusion Criteria:

1. Patients with cirrhosis confirmed by histology or liver stiffness or withunequivocal signs in ultrasound, endoscopy and/or blood tests

2. Clinically evident ascites due to portal hypertension

3. HRS-AKI

4. Age: ≥ 18 to ≤ 80 years old at the time of consent

5. ECOG < 4 prior to hospital admission

6. Subject has been informed of the nature of the study, is willing to comply with allrequired follow-up evaluations within the defined follow-up visit windows and hassigned an Ethics Committee (EC) approved consent form.

7. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 daysbefore the procedure and are willing to use a reliable method of birth control forthe duration of study participation. Female subjects will be exempted from thisrequirement in case they are sterile, infertile, or have been post-menopausal for atleast 12 months (no menses). A contraceptive method with a pearl index below 1% isassumed to be effective.

Exclusion Criteria:

1. Recent or current use of nephrotoxic drugs (NSAIDS, Aminoglycosides or high-dosediodinated contrast medium) in the previous 72 hours before AKI diagnosis

2. Improvement of renal function after 1 day of diuretic removal and plasma volumeexpansion with albumin 1-1.5 gr/kg

3. Uncontrolled shock within the last 48 hours prior to randomization

4. Patients with uncontrolled infection (defined by a 20 % increase in inflam-matoryparameters (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.

5. Patients with cardiac cirrhosis as defined by the development of cirrhosis in apatient with chronic heart failure due to a primary cardiac disease (is-chemiccardiomyopathy, hypertensive cardiomyopathy, etc.)

6. Patients with contraindications to TIPS placement (e.g. Bilirubin > 85.5 µmol/L (≙ 5mg/dL), recurrent hepatic encephalopathy, clinically relevant pulmonaryhypertension, aortic stenosis)

7. Patients with cavernous portal vein thrombosis, splenic vein thrombosis ormesenteric vein thrombosis

8. Patients with clinically significant cardiac disease (NYHA ≥ II)

9. Patients with diastolic dysfunction grade 3.

10. Patients with a reduced systolic function with an ejection fraction ≤ 50 %

11. Patients with ACLF grade 3

12. Patients with creatinine value > 442 µmol/L (≙ 5 mg/dL)

13. Patients with an acute variceal bleeding at the time of screening who haveindication for pre-emptive TIPS and/or terlipressin.

14. Patients with refractory ascites as defined by the International Ascites Club (< 800gr 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 ofdiuretics with complications secondary to the use of diuretics such as hyponatremia,renal failure, hepatic encephalopathy. *equivalent dose of torasemide 40 mg/day

15. Patients with hepatocellular carcinoma outside of the Milan criteria

16. Patients with hepatocellular carcinoma within the Milan criteria in whom the tumoris located in the puncture tract.

17. Patients with benign liver tumors (except regenerative nodules) which are located inthe puncture tract.

18. Patients who already have a TIPS placed

19. Patients who already had a liver transplantation

20. Patients with other comorbidities that lead to an estimated life expectancy under 1year.

21. Patients with respiratory insufficiency which requires mechanical ventila-tion

22. Patients with circulatory failure which requires administration of othervas-opressors (catecholamines)

23. Patients receiving renal replacement therapy

24. The subject is currently enrolled in another investigational device or drug trial.

25. Patients with pregnancy or lactation

26. Patients which are suspected to be incompliant for study participation.