Coated Devices to Decrease Infection in the Intensive Care Unit (CRITIC)

Hospital do Coracao

Status and phase: Completed; Phase 2; Phase 1

Conditions: Critically Ill

Treatments: Device: Coated devices; Device: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03868241

CRITIC_PILOT

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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103 participants in 2 patient groups, including a placebo group

Bactiguard-coated Devices

Experimental group

Description:

Patients will receive endotracheal tube, central venous catheter and urinary cather coated with gold, silver and palladium (Bactiguard coating)

Treatment:

Device: Coated devices

Control

Placebo Comparator group

Description:

Shelf endotracheal tube, central venous catheter and urinary cather available at each intensive care unit without any type of coating designed to prevent infection

Treatment:

Device: Control