TY - JOUR
T1 - Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery
T2 - The SIRAKI02 Randomized Clinical Trial
AU - Perez-Fernandez, Xose
AU - Ulsamer, Arnau
AU - Camara-Rosell, Maria
AU - Sbraga, Fabrizio
AU - Boza-Hernandez, Enric
AU - Moret-Ruiz, Enrique
AU - Plata-Menchaca, Erika
AU - Santiago-Bautista, Domenech
AU - Boronat-Garcia, Patricia
AU - Gumucio-Sanguino, Victor
AU - Penafiel-Munoz, Judith
AU - Camacho-Perez, Mercedes
AU - Betbese-Roig, Antoni
AU - Forni, Lui
AU - Campos-Gomez, Ana
AU - Sabater-Riera, Joan
N1 - Publisher Copyright:
© 2024 American Medical Association. All rights reserved.
PY - 2024/11/5
Y1 - 2024/11/5
N2 - 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 MeasuresThe 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. Trial RegistrationClinicalTrials.gov Identifier: NCT02518087
AB - 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 MeasuresThe 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. Trial RegistrationClinicalTrials.gov Identifier: NCT02518087
KW - Acrylonitrile
KW - Acute Kidney Injury/epidemiology
KW - Aged
KW - Cardiac Surgical Procedures/adverse effects
KW - Cardiopulmonary Bypass/adverse effects
KW - Double-Blind Method
KW - Female
KW - Hemofiltration/instrumentation
KW - Humans
KW - Incidence
KW - Male
KW - Membranes, Artificial
KW - Middle Aged
KW - Postoperative Complications/epidemiology
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=uab_pure&SrcAuth=WosAPI&KeyUT=WOS:001337068800003&DestLinkType=FullRecord&DestApp=WOS_CPL
UR - http://www.scopus.com/inward/record.url?scp=85208601416&partnerID=8YFLogxK
UR - http://www.ncbi.nlm.nih.gov/pubmed/39382234
UR - https://www.mendeley.com/catalogue/2e12c979-83a8-3a50-b914-88bdf06c2f3c/
U2 - 10.1001/jama.2024.20630
DO - 10.1001/jama.2024.20630
M3 - Article
C2 - 39382234
SN - 0002-9955
VL - 332
SP - 1446
EP - 1454
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 17
ER -