A Phase 1/2 interventional study of Coated devices and Control in Critically Ill, sponsored by Hospital do Coracao. Completed at 6 sites in Brazil. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-03-09.
Sponsored by Hospital do Coracao · Phase 1/2, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 103 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Hospital do Coracao is the lead sponsor of 66 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Newly added exclusion criteria in version 2.0:
Patients will receive endotracheal tube, central venous catheter and urinary cather coated with gold, silver and palladium (Bactiguard coating)
Device: Coated devices
Shelf endotracheal tube, central venous catheter and urinary cather available at each intensive care unit without any type of coating designed to prevent infection
Device: Control
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
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
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Hospital do Coracao