Fernando G Zampieri1, Neymar Elias de Oliveira2, Antonio Paulo Nassar3, Airton Leonardo de Oliveira Manoel4, Cintia Grion5, Fábio H Lacerda6, Israel Maia7, Marlus Thompson8, Thiago Simões Giancursi9, Priscilla de Aquino Martins10, Thiago Lisboa11, Tamiris Abait11, Lucas P Damiani12, Flávia R Machado13, Alexandre B Cavalcanti14. 1. Hospital do Coracao, 206379, Research Institute, Sao Paulo, Brazil; fgzampieri@gmail.com. 2. Hospital de Base, Rio Preto, Brazil. 3. AC Camargo Cancer Center, São Paulo, Brazil. 4. Hospital Paulistano, Sao Paulo, Brazil. 5. Hospital Evangélico, Londrina, Brazil. 6. Hospital da Lu, Sao Paulo, Brazil. 7. Hospital Nereu Ramos , Florianópolis, Brazil. 8. Hospital Evangélico Cachoeiro de Itapemirim, Cachoeiro de Itapemirim, Brazil. 9. Hospital Universitário do Oeste do Paraná, Cascavel, Brazil. 10. Hospital Estadual Jayme dos Santos Neves, Vila da Serra, Brazil. 11. Hospital do Coracao, Research Institute, Sao Paulo, Brazil. 12. Hospital do Coracao, 206379, Research Institute, Sao Paulo, Brazil. 13. University of Sao Paulo, Brazil, Chie, Intensive Care Department, Sao Paulo, Brazil. 14. Instituto Latino-Americano de Sepsis, Sao Paulo, Brazil.
Abstract
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).
RCT Entities:
RATIONALE: Coated devices may reduce biofilm formation and reduce occurrence of device-related infections in critically illpatients. 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).
Authors: Robinder G Khemani; Jessica T Lee; David Wu; Edward J Schenck; Margaret M Hayes; Patricia A Kritek; Gökhan M Mutlu; Hayley B Gershengorn; Rémi Coudroy Journal: Am J Respir Crit Care Med Date: 2021-05-01 Impact factor: 21.405