Original Investigation | Caring for the Critically Ill Patient
October 9, 2024
Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery: The SIRAKI02 Randomized Clinical Trial
Xosé Pérez-Fernández, Arnau Ulsamer, María Cámara-Rosell, et al
JAMA. Published online October 9, 2024. doi:10.1001/jama.2024.20630
Question Does the use of a nonselective extracorporeal blood purification (EBP) device connected to the cardiopulmonary bypass circuit reduce the incidence of acute kidney injury (AKI) in high-risk patients undergoing cardiothoracic surgery?
Findings In this randomized clinical trial that included 343 adults, a significant decrease in cardiac surgery–associated AKI was observed in those treated with EBP compared with those who were not (28.4% vs 39.7%).
Meaning In high-risk patients undergoing cardiac surgery, the use of a nonselective EBP device was associated with a significant reduction in AKI in the first 7 days after surgery.
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
