Transjugular intrahepatic portosystemic shunts for adults with hepatorenal syndrome.
Alejandro G Gonzalez-Garay, Aurora E Serralde-Zúñiga, Liliana Velasco Hidalgo...
https://pubmed.ncbi.nlm.nih.gov/38235907Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05346393
Hepatorenal Syndrome-Acute Kidney Injury Treatment With Transjugular Intrahepatic Portosystemic Shunt Versus Standard Therapy in Cirrhosis Patients A Randomized Controlled Trial
Led by Jena University Hospital · Updated on 2024-11-18
124
Participants Needed
14
Research Sites
52 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
This research aims to compare the effectiveness and safety of a procedure called TIPS (transjugular intrahepatic portosystemic shunt) versus standard drug therapy in patients with cirrhosis who develop hepatorenal syndrome-acute kidney injury (HRS-AKI) at various stages. Cirrhosis can lead to serious complications including kidney injury, and while current treatments improve kidney function, risks remain high. The study evaluates whether reducing pressure in the portal vein through TIPS placement can improve outcomes compared to standard care with drugs like terlipressin and albumin. Participants will be randomly assigned to receive either TIPS implantation plus standard care or standard medication therapy alone, which mainly involves terlipressin and albumin; noradrenaline may be used if terlipressin is not tolerated. The TIPS procedure creates a pathway to reduce portal vein pressure, potentially improving kidney function. The study is multicenter and will follow patients for at least 12 months to compare survival without liver transplant and other health outcomes. Throughout the study, participants will be monitored with regular assessments including survival rates up to 12 months, kidney function improvement, need for additional treatments, hospital stays, and quality of life measures. Safety and complications will also be tracked. The study aims to provide detailed information on how TIPS compares to standard drug therapy over time in patients with cirrhosis and HRS-AKI, with a focus on transplant-free survival and kidney health.
CONDITIONS
Brief Title
HRS-AKI Treatment With TIPS in Patients With Cirrhosis
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with cirrhosis confirmed by histology, liver stiffness, or clear signs in 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
- Willingness to comply with study follow-up and signed informed consent
- 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; exemptions apply for sterile, infertile, or postmenopausal women
You will not qualify if you...
- Use of nephrotoxic drugs (NSAIDs, aminoglycosides, or high-dose iodinated contrast) within 72 hours before AKI diagnosis
- Improvement of kidney function after 1 day of stopping diuretics and albumin plasma volume expansion
- Uncontrolled shock within 48 hours before randomization
- Uncontrolled infection despite 48 hours of antibiotics
- Cirrhosis due to primary heart disease (cardiac cirrhosis)
- Contraindications to TIPS such as high bilirubin, recurrent hepatic encephalopathy, pulmonary hypertension, or aortic stenosis
- Presence of portal, splenic, or mesenteric vein thrombosis
- Significant cardiac disease (NYHA class II or higher), diastolic dysfunction grade 3, or reduced systolic function (ejection fraction ≤ 50%)
- Acute-on-chronic liver failure grade 3
- Creatinine levels above 442 µmol/L
- Acute variceal bleeding needing pre-emptive TIPS or terlipressin
- Refractory ascites as defined by specific treatment responses
- Hepatocellular carcinoma outside Milan criteria or tumors in puncture tract
- Benign liver tumors (except regenerative nodules) in puncture tract
- Existing TIPS placement or prior liver transplantation
- Comorbidities causing life expectancy under 1 year
- Respiratory failure requiring mechanical ventilation
- Circulatory failure needing catecholamines
- Receiving renal replacement therapy
- Concurrent enrollment in other investigational trials
- Pregnancy or breastfeeding
- Suspected noncompliance with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Treatment
Duration - Up to 12 months
Participants receive either standard medication therapy with terlipressin and albumin or a transjugular intrahepatic portosystemic shunt (TIPS) implant along with standard therapy to treat hepatorenal syndrome-acute kidney injury (HRS-AKI).
Regular treatment and follow-up visits during the treatment period
Follow-up
Duration - Up to 12 months after baseline
Participants are monitored for outcomes including survival, recurrence of HRS-AKI, liver transplant status, and quality of life measures after treatment.
Approximately monthly visits during follow-up for up to 12 months
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
Loading map...
Research Team
C
Cristina Ripoll, Prof. Dr.
A
Alexander Zipprich, Prof. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Liver-HERO: hepatorenal syndrome-acute kidney injury (HRS-AKI) treatment with transjugular intrahepatic portosystemic shunt in patients with cirrhosis-a randomized controlled trial.
Cristina Ripoll, Stephanie Platzer, Philipp Franken...
https://pubmed.ncbi.nlm.nih.gov/37020315