Please use this identifier to cite or link to this item: http://dx.doi.org/10.25673/103461
Title: Liver-HERO : hepatorenal syndrome-acute kidney injury (HRS-AKI) treatment with transjugular intrahepatic portosystemic shunt in patients with cirrhosis : a randomized controlled trial
Author(s): Ripoll, CristinaLook up in the Integrated Authority File of the German National Library
Platzer, StephanieLook up in the Integrated Authority File of the German National Library
Franken, PhilippLook up in the Integrated Authority File of the German National Library
Aschenbach, RenéLook up in the Integrated Authority File of the German National Library
Wienke, AndreasLook up in the Integrated Authority File of the German National Library
Schuhmacher, Ulrike
Teichgräber, UlfLook up in the Integrated Authority File of the German National Library
Stallmach, AndreasLook up in the Integrated Authority File of the German National Library
Steighardt, Jörg
Zipprich, AlexanderLook up in the Integrated Authority File of the German National Library
Issue Date: 2023
Type: Article
Language: English
Abstract: Background: Patients with cirrhosis and ascites (and portal hypertension) are at risk of developing acute kidney injury (AKI). Although many etiologies exist, hepatorenal AKI (HRS-AKI) remains a frequent and difficult-to-treat cause, with a very high mortality when left untreated. The standard of care is the use of terlipressin and albumin. This can lead to reversal of AKI, which is associated to survival. Nevertheless, only approximately half of the patients achieve this reversal and even after reversal patients remains at risk for new episodes of HRS-AKI. TIPS is accepted for use in patients with variceal bleeding and refractory ascites, which leads to a reduction in portal pressure. Although preliminary data suggest it may be useful in HRS-AKI, its use in this setting is controversial and caution is recommended given the fact that HRS-AKI is associated to cardiac alterations and acute-on-chronic liver failure (ACLF) which represent relative contraindications for transjugular intrahepatic portosystemic shunt (TIPS). In the last decades, with the new definition of renal failure in patients with cirrhosis, patients are identified at an earlier stage. These patients are less sick and therefore more likely to not have contraindications for TIPS. We hypothesize that TIPS could be superior to the standard of care in patients with HRS-AKI. Methods: This study is a prospective, multicenter, open, 1:1-randomized, controlled parallel-group trial. The main end-point is to compare the 12-month liver transplant-free survival in patients assigned to TIPS compared to the standard of care (terlipressin and albumin). Secondary end-point include reversal of HRS-AKI, health-related Quality of Life (HrQoL), and incidence of further decompensation among others. Once patients are diagnosed with HRS-AKI, they will be randomized to TIPS or Standard of Care (SOC). TIPS should be placed within 72 h. Until TIPS placement, TIPS patients will be treated with terlipressin and albumin. Once TIPS is placed, terlipressin and albumin should be weaned off according to the attending physician. Discussion: If the trial were to show a survival advantage for patients who undergo TIPS placement, this could be incorporated in routine clinical practice in the management of patients with HRS-AKI.
URI: https://opendata.uni-halle.de//handle/1981185920/105413
http://dx.doi.org/10.25673/103461
Open Access: Open access publication
License: (CC BY 4.0) Creative Commons Attribution 4.0(CC BY 4.0) Creative Commons Attribution 4.0
Journal Title: Trials
Publisher: BioMed Central
Publisher Place: London
Volume: 24
Original Publication: 10.1186/s13063-023-07261-9
Page Start: 1
Page End: 14
Appears in Collections:Open Access Publikationen der MLU

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