Actively Recruiting
Comparing TIPS Procedure Versus Standard Medication for Treating Hepatorenal Syndrome-Acute Kidney Injury in Cirrhosis Patients
Led by Jena University Hospital · Updated on 2024-11-18
124
Participants Needed
14
Research Sites
52 weeks
Total Duration
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
Research Team
C
Cristina Ripoll, Prof. Dr.
A
Alexander Zipprich, Prof. Dr.
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