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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
103
Gold-silver-palladium coated devices (endotracheal tube, central venous catheter and urinary catheter) will be used whenever necessary. All three devices are required to be inserted as soon as possible after randomization and need for all three devices are the main inclusion criteria
Devices without coating available at each participating intensive care unit
Hospital de Base de São José do Rio Preto
Rio Preto, São Paulo, Brazil
Hospital do Coração
São Paulo, São Paulo, Brazil
AC Camargo Câncer Center
São Paulo, Brazil
Hospital da Luz
São Paulo, Brazil
Number of participants recruited in each center during the trial
Assess the recruitment rate
Time frame: Through study completion, an average of 1 year
Number of participants admitted to the intensive care unit that requires simultaneous insertion of endotracheal tube, central venous catheter and urinary catheter
Assess how many patients admitted to the intensive care unit will demand insertion of endotracheal tube, urinary catheter and central venous catheter after admission in all patients
Time frame: Through study completion, an average of 1 year
Feasibility - Occurence of sepsis
Occurrence of sepsis after admission in patients that require all three devices to be inserted in all patients
Time frame: 28 days
Sepsis
Occurrence of sepsis after randomization (defined as infection plus organ failure)
Time frame: 28 days
Occurence of ventilator-associated pneumonia
Occurence of ventilator-associated pneumonia by radiographic and clinical criteria
Time frame: 28 days
Occurence of central venous catheter-related bloodstream infection
Occurence of central venous catheter-related bloodstream infection using Brazilian regulatory agency criteria
Time frame: 28 days
Occurence of urinary catheter-related infection
Occurence of urinary catheter-related infection defined as positive urinary culture coupled with fever and without any other infection source
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Hospital Paulistano
São Paulo, Brazil
Hospital São Paulo - UNIFESP
São Paulo, Brazil
Time frame: 28 days
Rate of composite endpoint of ventilator-associated pneumonia and/or central venous catheter-related bloodstream infection and/or urinary catheter-related infection
Occurrence of any of the infections above
Time frame: 28 days
Antibiotic-free days
Number of days not receiving antibiotics
Time frame: 28 days
Number of patients that die in Intensive Care Unit
Mortality during intensive care unit stay
Time frame: Through intensive care unit stay, an average of 28 days
Number of patients that die during hospital stay
Mortality during hospital stay
Time frame: Through hospital stay, an average of 40 days