Intravascular device administration sets: Replacement after Standard Versus Prolonged use (The RSVP Trial)

Not Applicable

Completed

• Conditions: Intravascular device related blood stream infection; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12610000505000
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-18
• Study Completion: 2016-12-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2941

Inclusion Criteria

1. Informed written consent or waived consent (as per approving HREC) 2. Central venous or peripheral arterial IVD in situ. 3. IVD and AS have been insitu for equal to or more than 24 hours 4. IVD scheduled/expected use equal to or more than 7 days

Exclusion Criteria

Current bloodstream infection (within the previous 48 hours)
Planned removal of device less than or equal to 24 hours
IVD in situ >96 hours
Original AS already routinely replaced

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IVD-related Bloodstream Infection (IVD-BSI): (1) Primary bacteraemia/fungaemia with >=1 positive blood culture from a peripheral vein with no other identifiable source for the BSI other than the IVD, plus, one of: a positive semiquantitative (>15cfu) device culture, with the same organism (species and antibiogram) isolated from the device and blood, or (2) Two blood cultures (one from an IVD hub and one from a peripheral vein), that both meet the CRBSI criteria for differential time to positivity (DTP) (growth of the same microbe from hub drawn blood at least 2 hours before growth from the peripheral blood)[While IVD is in situ or within 48 hours of IVD removal]

Secondary Outcome Measures

Name	Time	Method
(i) IVD Colonisation: Growth of >15 CFU from distal segment of IVD tip on removal, using the semiquantitative culture method[Tips cultured on device removal];(ii) Administration set (AS) colonisation: Growth of 10^3 CFU/ml from infusate taken from the AS.[On removal of AS.];All cause BSI: Any positive blood culture result[While the IVD is in situ, or within 48 hours of removal.];(iv) All cause mortality: Mortality at hospital discharge[At hospital discharge];(v) Time the IVD was in situ.[At the time of IVD removal.];vi) AS per patient.[Number of AS used from time of study entry to IVD removal];(vii) Costs. AS consumable prices, staff time and treatment costs for IVD-BSI.[For the period of hospitalisation];Central Line Associated Bloodstream Infection (CLABSI) as defined by National Health and Safety Network/Centers for Disease Control definitions[While IVD is in situ or within 48 hours of removal ]