Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery: The SIRAKI02 Randomized Clinical Trial.

Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE

Original Publication: Chicago : American Medical Association, 1960-

Acute Kidney Injury*/epidemiology ; Acute Kidney Injury*/etiology ; Acute Kidney Injury*/prevention & control ; Cardiac Surgical Procedures*/adverse effects ; Cardiac Surgical Procedures*/methods ; Cardiopulmonary Bypass*/adverse effects ; Hemofiltration*/instrumentation ; Postoperative Complications*/epidemiology ; Postoperative Complications*/etiology ; Postoperative Complications*/prevention & control; Aged ; Female ; Humans ; Male ; Middle Aged ; Acrylonitrile ; Double-Blind Method ; Membranes, Artificial ; Incidence

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.
Trial Registration: ClinicalTrials.gov Identifier: NCT02518087.

Comment on: JAMA. 2024 Nov 5;332(17):1430-1431. doi: 10.1001/jama.2024.20928. (PMID: 39382233)

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Investigator: J Ballus Noguera; M Huguet Briba; R Máñez Mendiluce; F Esteve Urbano; E Santafosta Gómez; BH Alanez Saavedra; V Alonso Juste; L Anguela Calvet; RS Ávila Espinoza; P Cárdenas Campos; ML Carrió Cardona; T Casanovas Lorenzo; L Corral Ansa; VF Corral; E Farrero Bayarri; MP Fuset Cabanes; R Granada Vicente; JC López Delgado; N López Suñe; K Maisterra Santos; GJ Moreno; E Oliver Juan; M Pons Serra; E Periche Pedra; P Sastre Pérez; R Soley Corderas; D Rodríguez Castro; HR Torrado Santos; MD Belda Ley; FA Di Paolo; AC Lores; SM Luna Solis; AR Ochagavía Calvo; P Serra Paya; A Garcia Zaloña; G Via Clavero; E Boza Hernández; A Gil Dorado; A Bonet Burguera; E Mendez Arias; S Garcia Ballester; A Leon Moreno; RS Herrera; M Sanz Iturbe; J Toscano Fernández; F Sbraga; M Potocnik Potocnik; K Osorio Higa; A Miralles Cassina; D Ortiz Berbel; D Toral Sepúlveda; A Blasco Lucas; A Dantas; B Cevallos; J Tejero; L Martinez Sepena; F Iglesias Gordillo; MJ Bautista Correa; Y Gutiérrez; E Modrego Montiel; C Albendea Perell; J Castillo; E Bruguera; M Oliveras; S Badia Gamarra; E Berastegui Garcia; O Torres Aparicio; M Finestres Martin; S Buys; A Escudero Teixidó; E Massó Lago; F Ródenas Gómez; M Rodríguez Núñez; MT Sariñena Fernandez; M Ayala Gallardo; VJ Charlotte Philibert; M Sánchez Satorra; T Tomasa Irriguible; EA Valls Estrada; M Hueso; N Montero; M Estruch; J Ordoñez Llanos; L Hernandez Platero; R Rigo Bonnin; V Mora; A Arnaiz Francos; A Moreno Durán; ME Farigola Munuera; C Julià Valls; A Gonzalez Pujol; I Romera Peregrina; C Lerma Brianso; A Vera Martinez; S Prieto Palomino; J Carretero Aguilà; Querol Parra; L Torà Navarro; M Gonzalez Romero; L Gonzalez Barrera; E Puente Mora; M Briones Roc; J Pérez Sanchez; C Sanz Mellado; A Garcia-Morron Gallego; A Campoy; O Clavería; S Martinez Ocon; B Vazquez Guillamet; L Costa Capela; I Torreguitart; M Duran Colacios; A Puig Aragon; M Martinez Orellana; D Perez Soria; C Peribañez Biedma; S Gonzalez Del Hoyo; A Montoya Perez; M Sanchez Escudero; C Mendoza Jimenez; C Mesa Carrizosa; L Ibern Navarro; O Lopez Gonzalez; MA Burgos Naranjo; AM Moreno Duran; P Rodriguez Contreras; V Mora Muñiz; S Cabezas Garrido; A CarrionSanchez; M Ausio Navarro; L Gascon Tomas; V Fuentes Mila; A Chinchilla Perez; J Castaño Camuñez; R Nogales Ibañez; V Gimenez Vila; M Sanjuan Navais; D Rodriguez Gonzalez; A Gracia Martinez; V Ojeda Jimenez; S Hamed Loukili; L Perea Sanchez; R Buendia Flores; JM Ramos Puig; C Piquer Robles; L Marti Massanas; C Gil Ginebra; A Moreno Santoro; J Llamas Ruiz; S Hurtado Hidalgo; M Pujadas Fernandez-Cordeiro; A Barranco Rodriguez; T Olivera Rodriguez; A Cardenete Villarroyo; S Cruz Bardina; S Serrano Jaureguizar; A Del Rio Sanchez; M Llamas Bolta; C Gonzalez Lopez; RF Justel Garcia; B Ruiz de Pablo; D Figuereo Beltre; C Fernandez Gallego; I Julià Amill; L Delgado Ramis; B Romero Ferrer; R Roig Pineda; A Cabaña Benjumea; M Anglada Oliván; B Catalán Eraso; A Farré Estebe; V Ruiz Artola; E Bonet Cruces; E González Martínez; M Fabra Raduà; JM Manciño Contreras; S Martinez Vega; L Raguer Pardo; V Perez González; M Velázquez Torres; M Diago Ferré; C Blasco Torres; L Bielsa Berrocal; B Garces Gimeno; P Rodriguez Pedreira; G Muñoz Del Rio; D Bervel Franco; J Rodriguez Fanjul; E Benveniste Perez; F Chavez Diandreras; M Bauça Socies; T Pons López; DP Mota Montané; EE Coluccio Pereira

ClinicalTrials.gov NCT02518087

MP1U0D42PE (Acrylonitrile)
0 (Membranes, Artificial)

Date Created: 20241009 Date Completed: 20241105 Latest Revision: 20241108

20241108

PMC11539008

10.1001/jama.2024.20630

39382234