Study of Clindamycin Use as an Alternative to Vancomycin in Adults Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation to Prevent Infection

What this Trial Is About

Researchers are evaluating the use of clindamycin as an alternative antibiotic for patients undergoing cardiac surgery with Extracorporeal Circulation ECC. This study focuses on the pharmacokinetics of clindamycin, especially since many patients allergic to beta-lactam antibiotics currently receive vancomycin, which can cause adverse effects and is difficult to administer properly. The trial aims to verify that clindamycin maintains plasma concentrations above the minimum inhibition concentration MIC of key bacteria throughout surgery, potentially reducing surgical site infections. The study involves administering clindamycin intravenously during cardiac surgery with ECC. Patients receive an initial dose of 900 mg clindamycin slowly over 30 minutes after the first cefuroxime bolus, with a possible additional dose of 600 mg if surgery extends beyond four hours. Blood samples are taken at the start of surgery, hourly, and at sternal closure to measure clindamycin levels. The study also examines clindamycins diffusion in pericardial fatty tissue and tracks adverse events and protocol adherence. Participants are adults scheduled for cardiac surgery with ECC, consenting to the study and able to comply with its requirements. Researchers monitor plasma clindamycin concentrations during surgery using arterial catheter blood samples, minimizing discomfort. Outcomes include pharmacokinetic parameters, variability factors, pericardial tissue diffusion, and rates of post-operative mediastinitis and complications up to three months after surgery. Safety is assessed throughout hospitalization, and adherence to dosing protocols is tracked.

Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC)