Critically Ill
Conditions
Keywords
sepsis, ventilator-associated pneumonia, catheter related bloodstream infection, urinary catheter-related infection
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.
Interventions
DEVICECoated devices
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
DEVICEControl
Devices without coating available at each participating intensive care unit
Sponsors
Bactiguard AB
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants recruited in each center during the trial | Through study completion, an average of 1 year | Assess the recruitment rate |
| Number of participants admitted to the intensive care unit that requires simultaneous insertion of endotracheal tube, central venous catheter and urinary catheter | Through study completion, an average of 1 year | 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 |
| Feasibility - Occurence of sepsis | 28 days | Occurrence of sepsis after admission in patients that require all three devices to be inserted in all patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of central venous catheter-related bloodstream infection | 28 days | Occurence of central venous catheter-related bloodstream infection using Brazilian regulatory agency criteria |
| Occurence of urinary catheter-related infection | 28 days | Occurence of urinary catheter-related infection defined as positive urinary culture coupled with fever and without any other infection source |
| Number of patients that die during hospital stay | Through hospital stay, an average of 40 days | Mortality during hospital stay |
| Antibiotic-free days | 28 days | Number of days not receiving antibiotics |
| Number of patients that die in Intensive Care Unit | Through intensive care unit stay, an average of 28 days | Mortality during intensive care unit stay |
| Rate of composite endpoint of ventilator-associated pneumonia and/or central venous catheter-related bloodstream infection and/or urinary catheter-related infection | 28 days | Occurrence of any of the infections above |
| Sepsis | 28 days | Occurrence of sepsis after randomization (defined as infection plus organ failure) |
| Occurence of ventilator-associated pneumonia | 28 days | Occurence of ventilator-associated pneumonia by radiographic and clinical criteria |
Countries
Brazil
Outcome results
None listed