HRS-AKI Treatment With TIPS in Patients With Cirrhosis

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study compares the effectiveness and safety of TIPS implantation in patients with HRS-AKI (stage 2 and 3) and liver cirrhosis with standard therapy (drug therapy with terlipressin + albumin).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jena University Hospital
• Collaborators: Center for Clinical Studies, Jena University Hospital; German Research Foundation
• Treatments: Terlipressin

Criteria

Inclusion Criteria:

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

2. Clinically evident ascites due to portal hypertension (SAAG > 11 g/dL)

3. HRS-AKI stages 2 and 3

4. Planned vasoactive treatment for the management of HRS, as de-fined by the administration of terlipressin + albumin

5. Age between 18 and 75 years old at the time of consent

6. ECOG <4 prior to hospital admission

7. Subject has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined fol-low-up visit windows and has signed an Ethics Committee (EC) ap-proved consent form.

8. Female subjects of childbearing potential have a negative pregnan-cy test ≤ 7 days before the procedure and are willing to use a relia-ble 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:

1. Patients with signs of intrinsic renal disease as defined by pro-teinuria (>500 mg per day), microhematuria (>50 RBC per high power field) or signs of chronic renal disease on ultrasound.

2. Recent or current use of nephrotoxic drugs (NSAIDS, Aminoglycosides or iodinated contrast medium) in the previous 72 hours

3. Improvement of renal function after 2 days of diuretic removal and plasma volume expansion with albumin 1 gr/kg

4. Uncontrolled shock

5. Patients with uncontrolled infection (defined by a 50% increase in inflammatory 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.

6. Patients with cardiac cirrhosis as defined by the development of cirrhosis in a patient with a primary cardiac disease (ischemic cardi-omyopathy, hypertensive cardiomyopathy, etc.)

7. Patients with contraindications to TIPS placement (Bilirubin > 5 mg/dL, recurrent hepatic encephalopathy)

8. Patients with portal vein thrombosis

9. Patients with diastolic dysfunction grade 3.

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

11. Patients with refractory ascites as defined by the International Ascites Club (less than 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 hypo-natremia, renal failure, hepatic encephalopathy. *equivalent dose of torasemide 40 mg/day

12. Patients with hepatocellular carcinoma BCLC B or greater.

13. Patients with hepatocellular carcinoma BCLC A in whom the tumor is located in the puncture tract.

14. Patients with other comorbidities that lead to an estimated life ex-pectancy under 1 year.

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

16. Patients with pregnancy or lactation