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

Primary Purpose

Critically Ill

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Coated devices
Control
Sponsored by
Hospital do Coracao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill focused on measuring sepsis, ventilator-associated pneumonia, catheter related bloodstream infection, urinary catheter-related infection

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital do Coração
  • Hospital de Base de São José do Rio Preto
  • AC Camargo Câncer Center
  • Hospital da Luz
  • Hospital Paulistano
  • Hospital São Paulo - UNIFESP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bactiguard-coated Devices

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants recruited in each center during the trial
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
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
Occurrence of sepsis after admission in patients that require all three devices to be inserted in all patients

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2019
Last Updated
March 6, 2020
Sponsor
Hospital do Coracao
Collaborators
Bactiguard AB
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1. Study Identification

Unique Protocol Identification Number
NCT03868241
Brief Title
Coated Devices to Decrease Infection in the Intensive Care Unit
Acronym
CRITIC
Official Title
Randomized Controlled Open-label Trial Assessing the Efficacy of a Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 6, 2019 (Actual)
Primary Completion Date
February 13, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao
Collaborators
Bactiguard AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
Keywords
sepsis, ventilator-associated pneumonia, catheter related bloodstream infection, urinary catheter-related infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bactiguard-coated Devices
Arm Type
Experimental
Arm Description
Patients will receive endotracheal tube, central venous catheter and urinary cather coated with gold, silver and palladium (Bactiguard coating)
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Coated devices
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
Devices without coating available at each participating intensive care unit
Primary Outcome Measure Information:
Title
Number of participants recruited in each center during the trial
Description
Assess the recruitment rate
Time Frame
Through study completion, an average of 1 year
Title
Number of participants admitted to the intensive care unit that requires simultaneous insertion of endotracheal tube, central venous catheter and urinary catheter
Description
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
Time Frame
Through study completion, an average of 1 year
Title
Feasibility - Occurence of sepsis
Description
Occurrence of sepsis after admission in patients that require all three devices to be inserted in all patients
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Sepsis
Description
Occurrence of sepsis after randomization (defined as infection plus organ failure)
Time Frame
28 days
Title
Occurence of ventilator-associated pneumonia
Description
Occurence of ventilator-associated pneumonia by radiographic and clinical criteria
Time Frame
28 days
Title
Occurence of central venous catheter-related bloodstream infection
Description
Occurence of central venous catheter-related bloodstream infection using Brazilian regulatory agency criteria
Time Frame
28 days
Title
Occurence of urinary catheter-related infection
Description
Occurence of urinary catheter-related infection defined as positive urinary culture coupled with fever and without any other infection source
Time Frame
28 days
Title
Rate of composite endpoint of ventilator-associated pneumonia and/or central venous catheter-related bloodstream infection and/or urinary catheter-related infection
Description
Occurrence of any of the infections above
Time Frame
28 days
Title
Antibiotic-free days
Description
Number of days not receiving antibiotics
Time Frame
28 days
Title
Number of patients that die in Intensive Care Unit
Description
Mortality during intensive care unit stay
Time Frame
Through intensive care unit stay, an average of 28 days
Title
Number of patients that die during hospital stay
Description
Mortality during hospital stay
Time Frame
Through hospital stay, an average of 40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Biasi, MD/PhD
Organizational Affiliation
Hospital do Coração
Official's Role
Study Director
Facility Information:
Facility Name
Hospital do Coração
City
São Paulo
State/Province
SP
ZIP/Postal Code
04005000
Country
Brazil
Facility Name
Hospital de Base de São José do Rio Preto
City
Rio Preto
State/Province
São Paulo
Country
Brazil
Facility Name
AC Camargo Câncer Center
City
São Paulo
Country
Brazil
Facility Name
Hospital da Luz
City
São Paulo
Country
Brazil
Facility Name
Hospital Paulistano
City
São Paulo
Country
Brazil
Facility Name
Hospital São Paulo - UNIFESP
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32526149
Citation
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.
Results Reference
derived

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Coated Devices to Decrease Infection in the Intensive Care Unit

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