Coated Devices to Decrease Infection in the Intensive Care Unit

Critically Ill Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868241
• Other study ID #: CRITIC_PILOT
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 6, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: March 2020
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 28, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Infection

Intervention

Device:
• 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
• Control
Devices without coating available at each participating intensive care unit

Locations

Country	Name	City	State
Brazil	Hospital de Base de São José do Rio Preto	Rio Preto	São Paulo
Brazil	AC Camargo Câncer Center	São Paulo
Brazil	Hospital da Luz	São Paulo
Brazil	Hospital do Coração	São Paulo	SP
Brazil	Hospital Paulistano	São Paulo
Brazil	Hospital São Paulo - UNIFESP	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Coracao	Bactiguard AB

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited in each center during the trial	Assess the recruitment rate	Through study completion, an average of 1 year
Primary	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
Primary	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	Sepsis	Occurrence of sepsis after randomization (defined as infection plus organ failure)	28 days
Secondary	Occurence of ventilator-associated pneumonia	Occurence of ventilator-associated pneumonia by radiographic and clinical criteria	28 days
Secondary	Occurence of central venous catheter-related bloodstream infection	Occurence of central venous catheter-related bloodstream infection using Brazilian regulatory agency criteria	28 days
Secondary	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	28 days
Secondary	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	28 days
Secondary	Antibiotic-free days	Number of days not receiving antibiotics	28 days
Secondary	Number of patients that die in Intensive Care Unit	Mortality during intensive care unit stay	Through intensive care unit stay, an average of 28 days
Secondary	Number of patients that die during hospital stay	Mortality during hospital stay	Through hospital stay, an average of 40 days