Status:
RECRUITING
HRS-AKI Treatment With TIPS in Patients With Cirrhosis
Lead Sponsor:
Jena University Hospital
Collaborating Sponsors:
German Research Foundation
University Hospital Halle (Saale)
Conditions:
Cirrhosis, Liver
Hepatorenal Syndrome
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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).
Detailed Description
Cirrhosis is a major cause of global health burden worldwide. Acute kidney injury (AKI) occurs in 20% of hospitalized patients with cirrhosis. Acute kidney injury is a relatively new definition of ren...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
November 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT05346393
Start Date
November 29 2022
End Date
June 1 2026
Last Update
November 18 2024
Active Locations (14)
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1
University Hospital RWTH Aachen
Aachen, Germany, 52074
2
Charité - Universitätsmedizin Berlin CVK
Berlin, Germany, 13353
3
University Hospital Dresden, Medical Clinic I, Gastroenterology
Dresden, Germany, 01307
4
Universitätsklinikum Essen (AöR)
Essen, Germany, 45147