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
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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.</p><p><strong>Objective: </strong>To determine whether the use of an EBP device in a nonemergent cardiac surgery population reduces CSA-AKI after CPB.</p><p><strong>Design, setting, and participants: </strong>This 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.</p><p><strong>Intervention: </strong>Nonselective EBP device connected to the CPB circuit.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was the rate of CSA-AKI in the 7 days after randomization.</p><p><strong>Results: </strong>Among 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.</p><p><strong>Conclusions and relevance: </strong>The 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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT02518087.</p>","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11539008/pdf/","citationCount":"0","resultStr":"{\"title\":\"Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery: The SIRAKI02 Randomized Clinical Trial.\",\"authors\":\"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\",\"doi\":\"10.1001/jama.2024.20630\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>Cardiac 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.</p><p><strong>Objective: </strong>To determine whether the use of an EBP device in a nonemergent cardiac surgery population reduces CSA-AKI after CPB.</p><p><strong>Design, setting, and participants: </strong>This 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. 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Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery: The SIRAKI02 Randomized Clinical Trial.
Importance: Cardiac 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.
Objective: To determine whether the use of an EBP device in a nonemergent cardiac surgery population reduces CSA-AKI after CPB.
Design, setting, and participants: This 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.
Intervention: Nonselective EBP device connected to the CPB circuit.
Main outcomes and measures: The primary outcome was the rate of CSA-AKI in the 7 days after randomization.
Results: Among 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 relevance: The 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.
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JAMA, published continuously since 1883, is an international peer-reviewed general medical journal. JAMA is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications.
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