Coated Devices to Decrease Infection in the Intensive Care Unit

Randomized Controlled Open-label Trial Assessing the Efficacy of a Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit

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.

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