Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery
Xosé Pérez-Fernández, Arnau Ulsamer, María Luisa Cámara-Rosell, Fabrizio Sbraga, Enric Boza-Hernández, Enrique Moret-Ruíz, Erika P. Plata–Menchaca, Doménech Santiago-Bautista, Patricia Boronat-García, Víctor D. Gumucio-Sanguino, Judith Peñafiel-Muñoz, Mercedes Camacho-Pérez, Antoni Betbesé, Lui G. Forni, Ana Campos-Gómez, Joan Sabater‐Riera, SIRAKI02 Study Group, Josep Ballús Noguera, Marta Huguet Briba, Rafael Máñez Mendiluce, Francesc Esteve Urbano, Eva Santafosta Gómez, Beymar Henry Alanez Saavedra, V. Juste, Laura Anguela Calvet, Renzo Steve Ávila Espinoza, Paola Cárdenas Campos, Maria Cardona, Teodor Casanovas Lorenzo, Luisa Corral, Vicente Francisco Corral, Elisabet Farrero Bayarri, Mari Paz Fuset Cabanes, Rosa Granada Vicente, Juan Carlos Lopez‐Delgado, Neus López Suñe, Krystel Maisterra Santos, Gabriel Jesús Moreno, Eva Oliver Juan, Maria Pons Serra, Elisabet Periche Pedra, Paola Pérez, Ricard Soley Corderas, David Rodríguez Castro, Herminia Rosalía Torrado Santos, Maria-Dolores Belda Ley, Fabio Alessandro Di Paolo, Africa Lores, Stephani-Maria Luna Solis, Ana Rosa Ochagavía Calvo, Pablo Serra Paya, Alejandro Garcia Zaloña, G. Via-Clavero, E. Hernandez, Albert Gil Dorado, Antonia Bonet Burguera, Esther Mendez Arias, Sara Garcia Ballester, Ariadna Leon Moreno, Raul Senen Herrera, M. Iturbe, Jacobo Toscano Fernández, Fabrizio Sbraga, Marcos Potocnik Potocnik, Karina Osorio Higa, Albert Miralles Cassina, Daniel Ortiz Berbel, David Toral Sepúlveda, Arnau Blasco Lucas, Ana Dantas, Belén Cevallos, Javier Tejero, Luis Martinez Sepena, Francis Iglesias Gordillo, María José Bautista Correa, Yolanda Gutiérrez, Elena Montiel, Carlos Albendea Perell, Jordi Castillo, Elisenda Bruguera, Marga Oliveras, Sara Badía Gamarra, E. Garcia, Olga Torres Aparicio, Mónica Finestres Martin, Sara Buys, Adrià Escudero Teixidó, Eva Massó Lago, Frederic Ródenas Gómez, M. Rodriguez Núñez, Maria Fernandez, M. Gallardo, Viridiana Philibert, Marius Sánchez Satorra, Teresa Tomasa Irriguible, Elisabet Angela Valls Estrada, Miguel Hueso, Núria Montero, Montserrat Estruch, Jordi Ordóñez‐Llanos
Abstract
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.