Actively Recruiting
HRS-AKI Treatment With TIPS in Patients With Cirrhosis
Led by Jena University Hospital · Updated on 2024-11-18
124
Participants Needed
14
Research Sites
182 weeks
Total Duration
On this page
Sponsors
J
Jena University Hospital
Lead Sponsor
G
German Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
HRS-AKI Treatment With TIPS in Patients With Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with cirrhosis confirmed by biopsy, liver stiffness, or clear signs on ultrasound, endoscopy, or blood tests
- Clinically evident ascites caused by portal hypertension
- Diagnosis of hepatorenal syndrome-acute kidney injury (HRS-AKI)
- Age between 18 and 80 years at consent
- ECOG performance status less than 4 before hospital admission
- Informed consent signed and willingness to attend all follow-up visits
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before procedure and agree to use effective birth control during the study, unless sterile, infertile, or post-menopausal for at least 12 months
You will not qualify if you...
- Recent or current use of nephrotoxic drugs within 72 hours before AKI diagnosis
- Improvement of kidney function after 1 day of stopping diuretics and albumin volume expansion
- Uncontrolled shock within 48 hours before randomization
- Uncontrolled infection despite 48 hours of antibiotics
- Cardiac cirrhosis from primary heart disease
- Contraindications to TIPS (bilirubin over 5 mg/dL, recurrent hepatic encephalopathy, pulmonary hypertension, aortic stenosis)
- Presence of portal, splenic, or mesenteric vein thrombosis
- Significant cardiac disease (NYHA class II or higher)
- Severe diastolic dysfunction (grade 3)
- Reduced heart systolic function (ejection fraction 50% or less)
- Acute-on-chronic liver failure grade 3
- Creatinine value over 5 mg/dL
- Active acute variceal bleeding needing pre-emptive TIPS or terlipressin
- Refractory ascites as defined by weight loss and diuretic response criteria
- Hepatocellular carcinoma outside Milan criteria or tumor in puncture tract
- Benign liver tumors (except regenerative nodules) in puncture tract
- Existing TIPS or prior liver transplantation
- Other comorbidities limiting life expectancy to under 1 year
- Respiratory failure requiring mechanical ventilation
- Circulatory failure needing other vasopressors
- Receiving renal replacement therapy
- Currently enrolled in another investigational trial
- Pregnancy or breastfeeding
- Suspected inability to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
University Hospital RWTH Aachen
Aachen, Germany, 52074
Actively Recruiting
2
Charité - Universitätsmedizin Berlin CVK
Berlin, Germany, 13353
Not Yet Recruiting
3
University Hospital Dresden, Medical Clinic I, Gastroenterology
Dresden, Germany, 01307
Actively Recruiting
4
Universitätsklinikum Essen (AöR)
Essen, Germany, 45147
Not Yet Recruiting
5
University Hospital Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
6
University Hospital Halle
Halle, Germany, 06120
Actively Recruiting
7
University Hospital Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
8
Medical University Hannover
Hanover, Germany, 30625
Actively Recruiting
9
Jena University Hospital, Clinic for Inner Medicine IV
Jena, Germany, 07747
Actively Recruiting
10
Klinikum Landshut AdöR der Stadt Landshut
Landshut, Germany, 84034
Not Yet Recruiting
11
University Hospital Leipzig
Leipzig, Germany, 04103
Not Yet Recruiting
12
RKH Clinic Ludwigsburg
Ludwigsburg, Germany, 71640
Actively Recruiting
13
Ludwig-Maximilians-University, Klinikum Großhadern
Munich, Germany, 81377
Actively Recruiting
14
University Hospital Münster, Medical Clinic B
Münster, Germany, 48149
Actively Recruiting
Research Team
C
Cristina Ripoll, Prof. Dr.
CONTACT
A
Alexander Zipprich, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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