• Xosé Pérez-Fernández, Arnau Ulsamer, María Cámara-Rosell, Fabrizio Sbraga, Enric Boza-Hernández, Enrique Moret-Ruíz, Erika Plata-Menchaca, Doménech Santiago-Bautista, Patricia Boronat-García, Víctor Gumucio-Sanguino, Judith Peñafiel-Muñoz, Mercedes Camacho-Pérez, Antoni Betbesé-Roig, Lui Forni, Ana Campos-Gómez, Joan Sabater-Riera, and SIRAKI02 Study Group.
• Facultat de Medicina Campus de Bellvitge Universitat de Barcelona L'Hospitalet de Llobregat, Barcelona, Spain.
• JAMA. 2024 Oct 9.

ImportanceCardiac surgery-associated acute kidney injury (CSA-AKI) remains a significant problem following cardiopulmonary bypass (CPB). Various strategies are proposed to attenuate CSA-AKI, including extracorporeal blood purification (EBP), but little is known about the effect of EBP through an acrylonitrile-sodium methallylsulfonate/polyethyleneimine membrane during CPB.ObjectiveTo determine whether the use of an EBP device in a nonemergent cardiac surgery population reduces CSA-AKI after CPB.Design, Setting, And ParticipantsThis double-blind, randomized clinical trial was conducted in 2 tertiary hospitals in Spain. Patients 18 years or older undergoing nonemergent cardiac surgery who were at high risk for CSA-AKI were enrolled from June 15, 2016, through November 5, 2021, with follow-up data through February 5, 2022. Of 1156 patients assessed, 343 patients were randomized (1:1) to either receive EBP or standard care.InterventionNonselective EBP device connected to the CPB circuit.Main Outcomes And MeasuresThe primary outcome was the rate of CSA-AKI in the 7 days after randomization.ResultsAmong 343 patients randomized (169 to receive EBP and 174 to receive usual care), the mean (SD) age was 69 (9) years and 119 were females. The rate of CSA-AKI was 28.4% (95% CI, 21.7%-35.8%) in the EBP group vs 39.7% (95% CI, 32.3%-47.3%) in the standard care group (P = .03), with an adjusted difference of 10.4% (95% CI, 2.3%-18.5%) using a log-binomial model (P = .01). No significant differences (P > .05) were observed in most of the predefined clinical secondary end points or post hoc exploratory end points. In a sensitivity analysis, EBP was found to be more effective in terms of CSA-AKI reduction in patients with chronic kidney disease, diabetes, hypertension, low left ventricular ejection fraction (<40%), and lower body mass index (<30). No differences were observed between the groups in adverse events tracking.Conclusions And RelevanceThe use of a nonselective EBP device connected to the CPB circuit in a nonemergent population of patients undergoing cardiac surgery was associated with a significant reduction of CSA-AKI in the first 7 days after surgery.Trial RegistrationClinicalTrials.gov Identifier: NCT02518087.

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