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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03868241
Other study ID # CRITIC_PILOT
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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