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New treatment option for Cirrhosis, Liver
Official title HRS-AKI Treatment With TIPS in Patients With Cirrhosis
ClinicalTrials.gov ID: NCT05346393
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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
You likely can't join if
- Recent or current use of nephrotoxic drugs (NSAIDS, Aminoglycosides or high-dosed iodinated contrast medium) in the previous 72 hours before AKI...
- 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...
- Patients with cardiac cirrhosis as defined by the development of cirrhosis in a patient with chronic heart failure due to a primary cardiac disease...
- Patients with contraindications to TIPS placement (e.g. Bilirubin \> 85.5 µmol/L (≙ 5 mg/dL), recurrent hepatic encephalopathy, clinically relevant...
See the full eligibility criteria
- 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 people 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 people will...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aachen, Germany
- Berlin, Germany
- Dresden, Germany
- Essen, Germany
- Freiburg im Breisgau, Germany
- Halle, Germany
- Hamburg, Germany
- Hanover, Germany
- Jena, Germany
- Landshut, Germany
- Leipzig, Germany
- Ludwigsburg, Germany
- Munich, Germany
- Münster, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aachen, Germany; Berlin, Germany; Dresden, Germany; Essen, Germany; Freiburg im Breisgau, Germany; Halle, Germany and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.