HRS-AKI Treatment With TIPS in Patients With Cirrhosis

Recruiting now · Not applicable

Conditions studied: Cirrhosis, Liver, Hepatorenal Syndrome, Acute Kidney Injury, Ascites Hepatic

In brief

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).

Key facts

Study ID

NCT05346393

Run by

Jena University Hospital

People needed

124

Starts

2022-11-29

Expected to finish

2026-06-01

Last updated by the study team

2024-11-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University Hospital Münster, Medical Clinic B — Münster, Germany (enrolling)
• Jena University Hospital, Clinic for Inner Medicine IV — Jena, Germany (enrolling)
• RKH Clinic Ludwigsburg — Ludwigsburg, Germany (enrolling)
• Ludwig-Maximilians-University, Klinikum Großhadern — Munich, Germany (enrolling)
• University Hospital RWTH Aachen — Aachen, Germany (enrolling)
• University Hospital Dresden, Medical Clinic I, Gastroenterology — Dresden, Germany (enrolling)
• University Hospital Freiburg — Freiburg im Breisgau, Germany (enrolling)
• University Hospital Halle — Halle, Germany (enrolling)
• University Hospital Hamburg-Eppendorf — Hamburg, Germany (enrolling)
• Medical University Hannover — Hanover, Germany (enrolling)
• Charité - Universitätsmedizin Berlin CVK — Berlin, Germany
• Klinikum Landshut AdöR der Stadt Landshut — Landshut, Germany
• Universitätsklinikum Essen (AöR) — Essen, Germany
• University Hospital Leipzig — Leipzig, Germany

Full record on ClinicalTrials.gov

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