Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit: CRITIC Pilot Randomized Controlled Trial

RATIONALE Coated devices may reduce biofilm formation and reduce occurrence of device-related infections in critically ill patients. A bundle of coated devices (endotracheal tube - ETT, central venous catheter - CVC, urinary catheter - UC) simultaneously inserted may optimize benefits of coated devices in most severe patients. OBJECTIVES To assess feasibility of a randomized controlled trial on simultaneous insertion of gold-silver-palladium coated devices versus uncoated devices in severely ill patients required sequential insertion of all three devices (ETT, CVC and UC) for support in intensive care unit (ICU). METHODS Multi-center randomized controlled pilot trial. Patients that required simultaneous insertion of ETT, CVC and UC were randomized to coated versus uncoated devices which were used as necessary for up to 28 days. Primary endpoint was feasibility; secondary endpoints included estimating incidence of sepsis and device-associated infections (ventilator associated pneumonia [VAP], catheter related bloodstream infection [CRBI] and catheter related urinary tract infection [CRUTI]) for the whole population and within each group and number of days alive free of antibiotics during ICU stay. All events were adjudicated. RESULTS 103 patients (48 coated and 55 uncoated group) were included in the per-protocol analysis. There were 13 septic events in each group (26 in total), with an approximate incidence of sepsis of 32.3 (95% credible interval 22.4-44.9) per 100 patient-days. Overall incidence of VAP, CRUTI and CRBI were 15.2 (95% credible interval 7.8-26.4), 6.3 (95% credible interval 2.4-13.7), and 7.9 (95% credible interval 3.6-15.1) per 1,000 patient-days, which were not statistically different between groups. Patients in the coated group had more days alive free of antibiotics in the ICU (28.97 days versus 19.62 per 100 patient-days, mean ratio of 1.48, 95% credible interval 1.16-1.89). CONCLUSION Use of a bundle of coated devices as initial management of severely ill patients is feasible. Coated devices may be associated with more days alive and free of antibiotics. Clinical trial registered with ClinicalTrials.gov (NCT03868241).