Status:
COMPLETED
Coated Devices to Decrease Infection in the Intensive Care Unit
Lead Sponsor:
Hospital do Coracao
Collaborating Sponsors:
Bactiguard AB
Conditions:
Critically Ill
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03868241
Start Date
April 6 2019
End Date
February 28 2020
Last Update
March 9 2020
Active Locations (6)
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1
Hospital de Base de São José do Rio Preto
Rio Preto, São Paulo, Brazil
2
Hospital do Coração
São Paulo, São Paulo, Brazil, 04005000
3
AC Camargo Câncer Center
São Paulo, Brazil
4
Hospital da Luz
São Paulo, Brazil