Study Results
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Basic Information
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RECRUITING
NA
124 participants
INTERVENTIONAL
2022-11-29
2026-06-30
Brief Summary
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Detailed Description
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The standard treatment of HRS-AKI is with the infusion of albumin and terlipressin. Although this treatment improves renal function, patients remain at risk for new episodes of HRS-AKI and liver transplantation should be considered. Nevertheless, this optimal solution is only a reality for a privileged few given the shortage of organs and the common presence of contraindications.
Development of HRS-AKI is caused by increased pressure in the portal vein (the vein which brings the blood from the intestines to the liver), among other factors. Increased pressure in the portal vein, also called portal hypertension, is one of the main pathophysiological mechanisms that lead to the different complications of cirrhosis. Transjugular intrahepatic portosystemic shunt (TIPS) is an interventional radiological procedure which reduces the pressure in the portal vein by creating a short-cut between the portal vein and the hepatic vein, the vein which brings the blood from the liver towards the heart. TIPS placement has become the mainstay of treatment of some complications of cirrhosis, namely variceal bleeding and refractory ascites. Although rationally plausible, the use of TIPS in HRS-AKI has not been evaluated in the context of randomized controlled trials. Indirect data suggest that it could be helpful, since patients who become TIPS have an improvement in renal hemodynamics and renal function as well as less episodes of HRS-AKI in the follow-up. On the other hand, traditional HRS type 1 can be associated to liver failure and cardiac alterations which contraindicate TIPS placement. HRS-AKI includes not only traditional HRS type 1, but also milder forms of the disease, so that it is reasonable to consider that TIPS placement may have a role in this condition.
This study is a multicenter (14 centers), prospective, randomized controlled trial which evaluates use of TIPS in patients with HRS-AKI (stage 1, 2 and 3) versus standard of care (albumin and terlipressin). Patients with cirrhosis and HRS-AKI who fulfill the inclusion criteria and do not have any exclusion criteria will be randomized to standard of care or standard of care and TIPS. Patients will be followed for a minimum of 12 months until the end of the trial. The main end-point is to compare the survival at the end of follow-up among the two groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TIPS group
TIPS implant (transjugular intrahepatic portosystemic shunt)
TIPS
A transjugular intrahepatic portosystemic shunt (TIPS) is implanted into the cirrhotic liver
Control group
Standard medication therapy with terlipressin and albumin. In the case Terlipressin is not tolerated treatment with Noradrenaline may be considered following actual guidelines.
Standard of Care
Terlipressin/Albumin treatment is the preferred standard of care treatment. In the case Terlipressin is not tolerated treatment with Noradrenaline may be considered following actual guidelines.
Interventions
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TIPS
A transjugular intrahepatic portosystemic shunt (TIPS) is implanted into the cirrhotic liver
Standard of Care
Terlipressin/Albumin treatment is the preferred standard of care treatment. In the case Terlipressin is not tolerated treatment with Noradrenaline may be considered following actual guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinically evident ascites due to portal hypertension
3. HRS-AKI
4. Age: ≥ 18 to ≤ 80 years old at the time of consent
5. ECOG \< 4 prior to hospital admission
6. 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.
7. 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 Criteria
2. Improvement of renal function after 1 day of diuretic removal and plasma volume expansion with albumin 1-1.5 gr/kg
3. Uncontrolled shock within the last 48 hours prior to randomization
4. 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.
5. 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.)
6. 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)
7. Patients with cavernous portal vein thrombosis, splenic vein thrombosis or mesenteric vein thrombosis
8. Patients with clinically significant cardiac disease (NYHA ≥ II)
9. Patients with diastolic dysfunction grade 3.
10. Patients with a reduced systolic function with an ejection fraction ≤ 50 %
11. Patients with ACLF grade 3
12. Patients with creatinine value \> 442 µmol/L (≙ 5 mg/dL)
13. Patients with an acute variceal bleeding at the time of screening who have indication for pre-emptive TIPS and/or terlipressin.
14. 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
15. Patients with hepatocellular carcinoma outside of the Milan criteria
16. Patients with hepatocellular carcinoma within the Milan criteria in whom the tumor is located in the puncture tract.
17. Patients with benign liver tumors (except regenerative nodules) which are located in the puncture tract.
18. Patients who already have a TIPS placed
19. Patients who already had a liver transplantation
20. Patients with other comorbidities that lead to an estimated life expectancy under 1 year.
21. Patients with respiratory insufficiency which requires mechanical ventila-tion
22. Patients with circulatory failure which requires administration of other vas-opressors (catecholamines)
23. Patients receiving renal replacement therapy
24. The subject is currently enrolled in another investigational device or drug trial.
25. Patients with pregnancy or lactation
26. Patients which are suspected to be incompliant for study participation.
18 Years
80 Years
ALL
No
Sponsors
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German Research Foundation
OTHER
University Hospital Halle (Saale)
UNKNOWN
Jena University Hospital
OTHER
Responsible Party
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Cristina Ripoll
Prof. Dr.
Principal Investigators
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Cristina Ripoll, Prof. Dr.
Role: STUDY_DIRECTOR
Jena University Hospital
Locations
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University Hospital RWTH Aachen
Aachen, , Germany
Charité - Universitätsmedizin Berlin CVK
Berlin, , Germany
University Hospital Dresden, Medical Clinic I, Gastroenterology
Dresden, , Germany
Universitätsklinikum Essen (AöR)
Essen, , Germany
University Hospital Freiburg
Freiburg im Breisgau, , Germany
University Hospital Halle
Halle, , Germany
University Hospital Hamburg-Eppendorf
Hamburg, , Germany
Medical University Hannover
Hanover, , Germany
Jena University Hospital, Clinic for Inner Medicine IV
Jena, , Germany
Klinikum Landshut AdöR der Stadt Landshut
Landshut, , Germany
University Hospital Leipzig
Leipzig, , Germany
RKH Clinic Ludwigsburg
Ludwigsburg, , Germany
Ludwig-Maximilians-University, Klinikum Großhadern
Munich, , Germany
University Hospital Münster, Medical Clinic B
Münster, , Germany
Countries
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Central Contacts
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Facility Contacts
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Cornelius Engelmann, PD Dr.
Role: primary
Jassin Rashidi Alavijeh, PD Dr.
Role: primary
Marko Damm, Dr.
Role: primary
Matthias Dollinger, Prof. Dr.
Role: primary
References
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Gonzalez-Garay AG, Serralde-Zuniga AE, Velasco Hidalgo L, Flores Garcia NC, Aguirre-Salgado MI. Transjugular intrahepatic portosystemic shunts for adults with hepatorenal syndrome. Cochrane Database Syst Rev. 2024 Jan 18;1(1):CD011039. doi: 10.1002/14651858.CD011039.pub2.
Ripoll C, Platzer S, Franken P, Aschenbach R, Wienke A, Schuhmacher U, Teichgraber U, Stallmach A, Steighardt J, Zipprich A; Liver-HERO Study Group. Liver-HERO: hepatorenal syndrome-acute kidney injury (HRS-AKI) treatment with transjugular intrahepatic portosystemic shunt in patients with cirrhosis-a randomized controlled trial. Trials. 2023 Apr 5;24(1):258. doi: 10.1186/s13063-023-07261-9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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DE-22-00013779
Identifier Type: OTHER
Identifier Source: secondary_id
431667134
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ZKSJ0146
Identifier Type: -
Identifier Source: org_study_id
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