Clinical trial NCT03868241: Coated Devices to Decrease Infection in the Intensive Care Unit
Official title: Randomized Controlled Open-label Trial Assessing the Efficacy of a Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Critically Ill
Keywords: sepsis
ventilator-associated pneumonia
catheter related bloodstream infection
urinary catheter-related infection
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Bactiguard AB
First posted: 2019-03-11
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilot explanatory, randomized, open label, controlled trial. Critically ill patients which will demand placement of invasive devices for organ support (endotracheal tube, central venous catheter and urinary Foley catheter) will be randomized 1:1 to receive coated (Bactiguard®) or habitual (non-coated) devices.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the intensive care unit which will require simultaneous insertion of all three devices (endotracheal tube, central venous catheter and urinary catheter) due to illness severity as defined by the attending physician.

Exclusion Criteria:

* Patients admitted to the intensive care unit for more than 48 hours or admitted in the hospital for more than seven days
* Presence of any of the invasive devices (endotracheal tube, central venous catheter or urinary catheters) before randomization and absence of the intention to exchange the devices;
* Previous use of any type of coated devices;
* Age \< 18 years;
* Known pregnancy
* Known allergy to gold, silver and palladium;
* Suspected or confirmed brain death;
* Previously enrolled in the study

Newly added exclusion criteria in version 2.0:

* Severe chronic pulmonary obstructive disease which may limit catheter site selection
* Previous irradiation and/or thrombosis in site selected for catheter insertion

Primary outcomes:
measure: Number of participants recruited in each center during the trial
timeFrame: Through study completion, an average of 1 year
measure: Number of participants admitted to the intensive care unit that requires simultaneous insertion of endotracheal tube, central venous catheter and urinary catheter
timeFrame: Through study completion, an average of 1 year
measure: Feasibility - Occurence of sepsis
timeFrame: 28 days
Secondary outcomes:
measure: Sepsis
timeFrame: 28 days
measure: Occurence of ventilator-associated pneumonia
timeFrame: 28 days
measure: Occurence of central venous catheter-related bloodstream infection
timeFrame: 28 days
measure: Occurence of urinary catheter-related infection
timeFrame: 28 days
measure: Rate of composite endpoint of ventilator-associated pneumonia and/or central venous catheter-related bloodstream infection and/or urinary catheter-related infection
timeFrame: 28 days
measure: Antibiotic-free days
timeFrame: 28 days
measure: Number of patients that die in Intensive Care Unit
timeFrame: Through intensive care unit stay, an average of 28 days
measure: Number of patients that die during hospital stay
timeFrame: Through hospital stay, an average of 40 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Coração
state: SP
city: Rio Preto
country: Brazil
facility: Hospital de Base de São José do Rio Preto
state: São Paulo
city: São Paulo
country: Brazil
facility: AC Camargo Câncer Center
city: São Paulo
country: Brazil
facility: Hospital da Luz
city: São Paulo
country: Brazil
facility: Hospital Paulistano
city: São Paulo
country: Brazil
facility: Hospital São Paulo - UNIFESP
Study officials:
affiliation: Hospital do Coração
name: Alexandre Biasi, MD/PhD
role: STUDY_DIRECTOR
References:
citation: Zampieri FG, de Oliveira NE, Nassar AP Jr, de Oliveira Manoel AL, Grion C, Lacerda FH, Maia I, Thompson M, Giancursi TS, de Aquino Martins P, Lisboa T, Abait T, Damiani LP, Machado FR, Cavalcanti AB; BRICNet. Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit. CRITIC Pilot Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Oct;17(10):1257-1263. doi: 10.1513/AnnalsATS.202003-206OC.