Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study
Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery
Monash University
9,180 participants
Feb 7, 2023
INTERVENTIONAL
Conditions
Summary
This multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial will compare the incidence of surgical site infection and other healthcare associated infections, health economic and microbiological impact after intraoperative only (Arm A), to 24 hours (Arm B) and, to 48 hours (Arm C) of IV cefazolin and placebo postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery
Eligibility
Inclusion Criteria1
- \- Adult patients undergoing cardiac surgery involving a median sternotomy
Exclusion Criteria10
- Age \<18 years
- American Society of Anesthesiology (ASA) 5
- Subjects with GFR \<40mL/min/1.73m2 or those requiring continuous renal replacement therapy, haemodialysis or peritoneal dialysis
- Surgery for suspected or proven endocarditis or deep sternal wound infection
- Documented cefazolin hypersensitivity
- Documented methicillin resistant Staphylococcus aureus (MRSA) colonisation or infection in the 12-months prior to index surgery
- Cardiac transplantation
- Procedures involving insertion ventricular assist device or mechanical circulatory support device
- Procedures not involving a median sternotomy
- Patients previously enrolled and randomised to the CALIPSO trial
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Interventions
Intravenous administration of 2 g cefazolin
Intravenous administration of 10mL sterile water for injection
Locations(27)
View Full Details on ClinicalTrials.gov
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NCT05447559