SIRAKI 02 Posthoc Analysis.

The study was conducted in two university centres of the Barcelona metropolitan area between 2016 and 2022 randomising 343 patients (1:1) to receive either an intervention strategy with EBP connected to the CPB circuit (169 patients) or a standard strategy with CPB alone (174 patients). Cefuroxime was employed as antibiotic prophylaxis in 223 patients and Cefazolin was employed as antibiotic prophylaxis in the other 120 patients. These variations were due to the different hospital protocols for cardiac surgery antibiotic prophylaxis. In 205 patients (111 in the control group and 94 in the EBP group), we recollected blood samples that were centrifuged, aliquoted and stored at -70º Celsius. 119 patients received Cefazolin protocol prophylaxis and 86 patients received Cefuroxime protocol prophylaxis. The samples from these patients were obtained at the beginning of the surgical intervention (T0), at the clamp withdrawal (T1), at the ICU admission (T2) and 24 hours after (T3). To evaluate the primary endpoint, antibiotic mass concentrations in plasma samples from T1 checkpoint will be measured using a previously validated ultra-high-performance liquid chromatography-tandem mass spectrometry method (Rigo-Bonnin R, Ribera A, Arbiol-Roca A, et al. Development and validation of a measurement procedure based on ultra-high performance liquid chromatography-tandem mass spectrometry for simultaneous measurement of β-lactam antibiotic concentration in human plasma. Clin Chim Acta. 2017;468:215-24). In all patients (343 patients, 174 in the control group and 169 in the EBP group), we have planned to complete collecting all the hemodynamic and respiratory data in the operating room (OR) besides all the drugs administered in the OR (antibiotics, heparin, protamine, norepinephrine, insulin, and propofol). Laboratory parameters during surgery will be obtained from the medical records. Specific CPB parameters and ultrafiltration data when performed will also be collected. Kidney function parameters (creatinine and other biomarkers) will be registered up to 90 days after cardiac surgery and CKD incidence will be monitored up to 1 year after cardiac surgery.