Coated Devices to Decrease Infection in the Intensive Care Unit

Phase 1

Completed

• Conditions: Critically Ill
• Interventions: Device: Control; Device: Coated devices

• Registration Number: NCT03868241
• Lead Sponsor: Hospital do Coracao

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-11
• Study Start: 2019-04-06
• Primary Completion: 2020-02-13
• Study Completion: 2020-02-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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
Bactiguard-coated Devices	Coated devices	Patients will receive endotracheal tube, central venous catheter and urinary cather coated with gold, silver and palladium (Bactiguard coating)

Primary Outcome Measures

Name	Time	Method
Number of participants recruited in each center during the trial	Through study completion, an average of 1 year	Assess the recruitment rate
Number of participants admitted to the intensive care unit that requires simultaneous insertion of endotracheal tube, central venous catheter and urinary catheter	Through study completion, an average of 1 year	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
Feasibility - Occurence of sepsis	28 days	Occurrence of sepsis after admission in patients that require all three devices to be inserted in all patients

Secondary Outcome Measures

Name	Time	Method
Sepsis	28 days	Occurrence of sepsis after randomization (defined as infection plus organ failure)
Occurence of urinary catheter-related infection	28 days	Occurence of urinary catheter-related infection defined as positive urinary culture coupled with fever and without any other infection source
Occurence of ventilator-associated pneumonia	28 days	Occurence of ventilator-associated pneumonia by radiographic and clinical criteria
Occurence of central venous catheter-related bloodstream infection	28 days	Occurence of central venous catheter-related bloodstream infection using Brazilian regulatory agency criteria
Rate of composite endpoint of ventilator-associated pneumonia and/or central venous catheter-related bloodstream infection and/or urinary catheter-related infection	28 days	Occurrence of any of the infections above
Antibiotic-free days	28 days	Number of days not receiving antibiotics
Number of patients that die in Intensive Care Unit	Through intensive care unit stay, an average of 28 days	Mortality during intensive care unit stay
Number of patients that die during hospital stay	Through hospital stay, an average of 40 days	Mortality during hospital stay

Trial Locations

Locations (6)

Hospital do Coração; 🇧🇷 São Paulo, SP, Brazil

Hospital de Base de São José do Rio Preto; 🇧🇷 Rio Preto, São Paulo, Brazil

Hospital da Luz; 🇧🇷 São Paulo, Brazil

AC Camargo Câncer Center; 🇧🇷 São Paulo, Brazil

Hospital Paulistano; 🇧🇷 São Paulo, Brazil

Hospital São Paulo - UNIFESP; 🇧🇷 São Paulo, Brazil