Coated Devices to Decrease Infection in the Intensive Care Unit

NCT03868241 | Completed Phase 1

• 1 other identifier: CRITIC_PILOT
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 6

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.

Conditions

Critically Ill

Keywords

sepsis; ventilator-associated pneumonia; catheter related bloodstream infection; urinary catheter-related infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Sepsis

  28 days

• Occurence of ventilator-associated pneumonia

  28 days

• Occurence of central venous catheter-related bloodstream infection

  28 days

• Occurence of urinary catheter-related infection

  28 days

• Rate of composite endpoint of ventilator-associated pneumonia and/or central venous catheter-related bloodstream infection and/or urinary catheter-related infection

  28 days

Study Arms (2)

Bactiguard-coated Devices

EXPERIMENTAL

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

Device: Coated devices

Control

PLACEBO COMPARATOR

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

Interventions

Coated devices 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

Bactiguard-coated Devices

Control DEVICE

Devices without coating available at each participating intensive care unit

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital do Coracao: lead
• Bactiguard AB: collaborator

Study Sites (6)

Hospital de Base de São José do Rio Preto

Rio Preto, São Paulo, Brazil

Location

Hospital do Coração

São Paulo, São Paulo, 04005000, Brazil

Location

AC Camargo Câncer Center

São Paulo, Brazil

Location

Hospital da Luz

São Paulo, Brazil

Location

Hospital Paulistano

São Paulo, Brazil

Location

Hospital São Paulo - UNIFESP

São Paulo, Brazil

Location

Related Publications (1)

• Zampieri FG, de Oliveira NE, Nassar AP Jr, de Oliveira Manoel AL, Grion C, Lacerda FH, Maia I, Thompson M, Giancursi TS, de Aquino Martins P, Lisboa T, Abait T, Damiani LP, Machado FR, Cavalcanti AB; BRICNet. Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit. CRITIC Pilot Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Oct;17(10):1257-1263. doi: 10.1513/AnnalsATS.202003-206OC.

  PMID: 32526149 DERIVED

MeSH Terms

Conditions

Critical Illness; Sepsis; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease

Study Officials

• Alexandre Biasi, MD/PhD

  Hospital do Coração

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 11, 2019
• Study Start: April 6, 2019
• Primary Completion: February 13, 2020
• Study Completion: February 28, 2020
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (6)