Coated Devices to Decrease Infection in the Intensive Care Unit

Study Overview
=================
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.

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

Conditions
-----------------
Critically Ill

Intervention / Treatment
-----------------
* Device: Coated devices
* Device: Control


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bactiguard-coated Devices<br>Patients will receive endotracheal tube, central venous catheter and urinary cather coated with gold, silver and palladium (Bactiguard coating) | Device: Coated devices<br>* 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<br>|
| Placebo Comparator: Control<br>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<br>* Devices without coating available at each participating intensive care unit<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, ventilator-associated pneumonia, catheter related bloodstream infection, urinary catheter-related infection