Coated Devices to Decrease Infection in the Intensive Care Unit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-06

Study Completion Date

2020-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bactiguard-coated Devices

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

Group Type EXPERIMENTAL

Coated devices

Intervention Type 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

Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DEVICE

Devices without coating available at each participating intensive care unit

Interventions

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Coated 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

Intervention Type DEVICE

Control

Devices without coating available at each participating intensive care unit

Intervention Type DEVICE

Eligibility Criteria

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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

* Severe chronic pulmonary obstructive disease which may limit catheter site selection
* Previous irradiation and/or thrombosis in site selected for catheter insertion

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No