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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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (14 locations)

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