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| Name | Class |
|---|---|
| Bactiguard AB | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bactiguard-coated Devices | Experimental | Patients will receive endotracheal tube, central venous catheter and urinary cather coated with gold, silver and palladium (Bactiguard coating) |
|
| Control | Placebo Comparator | Shelf endotracheal tube, central venous catheter and urinary cather available at each intensive care unit without any type of coating designed to prevent infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coated devices | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants recruited in each center during the trial | Assess the recruitment rate | 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 | 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 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sepsis | Occurrence of sepsis after randomization (defined as infection plus organ failure) | 28 days |
| Occurence of ventilator-associated pneumonia | Occurence of ventilator-associated pneumonia by radiographic and clinical criteria |
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Inclusion Criteria:
Exclusion Criteria:
Newly added exclusion criteria in version 2.0:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Biasi, MD/PhD | Hospital do Coração | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Base de São José do Rio Preto | Rio Preto | São Paulo | Brazil | |||
| Hospital do Coração |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32526149 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 3, 2019 | Oct 30, 2019 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D018805 | Sepsis |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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|
| Control | Device | Devices without coating available at each participating intensive care unit |
|
| 28 days |
| Occurence of central venous catheter-related bloodstream infection | Occurence of central venous catheter-related bloodstream infection using Brazilian regulatory agency criteria | 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 | 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 | 28 days |
| Antibiotic-free days | Number of days not receiving antibiotics | 28 days |
| Number of patients that die in Intensive Care Unit | Mortality during intensive care unit stay | Through intensive care unit stay, an average of 28 days |
| Number of patients that die during hospital stay | Mortality during hospital stay | Through hospital stay, an average of 40 days |
| São Paulo |
| São Paulo |
| 04005000 |
| Brazil |
| AC Camargo Câncer Center | São Paulo | Brazil |
| Hospital da Luz | São Paulo | Brazil |
| Hospital Paulistano | São Paulo | Brazil |
| Hospital São Paulo - UNIFESP | São Paulo | Brazil |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |