Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000505000
Ethics application status
Approved
Date submitted
21/05/2010
Date registered
18/06/2010
Date last updated
23/04/2019
Date data sharing statement initially provided
23/04/2019
Date results information initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravascular device administration sets: Replacement after Standard Versus Prolonged use (The RSVP Trial)
Scientific title
Intravascular device (IVD) administration sets: a comparison of IVD-related Bloodstream Infection between Replacement after Standard Versus Prolonged use (The RSVP Trial)
Secondary ID [1] 251869 0
Nil
Universal Trial Number (UTN)
Trial acronym
RSVP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intravascular device related blood stream infection 257433 0
Condition category
Condition code
Infection 257580 257580 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in this study have intravascular devices (IVDs) used in medical, surgical, intensive care, oncology and haematology units, and include adult and paediatric patients. Patients will have their administration set replaced every 7 days. This will continue for the course of their intravenous (IV) therapy.
Intervention code [1] 256532 0
Prevention
Comparator / control treatment
Patients will have their intravascular devices replaced every 4 days for the course of their IV therapy.
Control group
Active

Outcomes
Primary outcome [1] 288908 0
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)
Timepoint [1] 288908 0
While IVD is in situ or within 48 hours of IVD removal
Secondary outcome [1] 264297 0
(i) IVD Colonisation: Growth of >15 CFU from distal segment of IVD tip on removal, using the semiquantitative culture method
Timepoint [1] 264297 0
Tips cultured on device removal
Secondary outcome [2] 264342 0
(ii) Administration set (AS) colonisation: Growth of 10^3 CFU/ml from infusate taken from the AS.
Timepoint [2] 264342 0
On removal of AS.
Secondary outcome [3] 264343 0
All cause BSI: Any positive blood culture result
Timepoint [3] 264343 0
While the IVD is in situ, or within 48 hours of removal.
Secondary outcome [4] 264344 0
(iv) All cause mortality: Mortality at hospital discharge
Timepoint [4] 264344 0
At hospital discharge
Secondary outcome [5] 264345 0
(v) Time the IVD was in situ.
Timepoint [5] 264345 0
At the time of IVD removal.
Secondary outcome [6] 264346 0
vi) AS per patient.
Timepoint [6] 264346 0
Number of AS used from time of study entry to IVD removal
Secondary outcome [7] 264347 0
(vii) Costs. AS consumable prices, staff time and treatment costs for IVD-BSI.
Timepoint [7] 264347 0
For the period of hospitalisation
Secondary outcome [8] 369627 0
Central Line Associated Bloodstream Infection (CLABSI) as defined by National Health and Safety Network/Centers for Disease Control definitions
Timepoint [8] 369627 0
While IVD is in situ or within 48 hours of removal

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated allocation provided by electronic data collection device. Allocation is concealed until the patient is randomised
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/05/2011
Actual
30/05/2011
Date of last participant enrolment
Anticipated
Actual
9/12/2016
Date of last data collection
Anticipated
Actual
15/12/2016
Sample size
Target
2939
Accrual to date
Final
2941
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 4973 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 4974 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 4975 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 4976 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [5] 4977 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 4978 0
Royal Children's Hospital - Herston
Recruitment hospital [7] 4979 0
The Prince Charles Hospital - Chermside
Recruitment hospital [8] 4980 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [9] 4981 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [10] 7372 0
St John of God Hospital, Murdoch - Murdoch
Recruitment postcode(s) [1] 15167 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 257017 0
Charities/Societies/Foundations
Name [1] 257017 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 257017 0
Australia
Funding source category [2] 257018 0
Charities/Societies/Foundations
Name [2] 257018 0
Gold Coast Hospital Foundation
Country [2] 257018 0
Australia
Funding source category [3] 267110 0
Government body
Name [3] 267110 0
NHMRC
Country [3] 267110 0
Australia
Funding source category [4] 292571 0
Charities/Societies/Foundations
Name [4] 292571 0
Cancer Nurses' Society of Australia
Country [4] 292571 0
Australia
Funding source category [5] 292572 0
Charities/Societies/Foundations
Name [5] 292572 0
Australian College of Critical Care Nurses (Qld)
Country [5] 292572 0
Australia
Funding source category [6] 292573 0
University
Name [6] 292573 0
Griffith University
Country [6] 292573 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus, 170 Kessels Road, Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 256278 0
None
Name [1] 256278 0
Address [1] 256278 0
Country [1] 256278 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259037 0
Gold Coast Health Service District Human Research Ethics Committee via the Queensland Health Multi-Site Ethics review process
Ethics committee address [1] 259037 0
Office of the Human Research Ethics Committee
Gold Coast Health Service District
Little High Street, Southport QLD 4215
Ethics committee country [1] 259037 0
Australia
Date submitted for ethics approval [1] 259037 0
10/06/2010
Approval date [1] 259037 0
04/11/2010
Ethics approval number [1] 259037 0
Ethics committee name [2] 294049 0
Children's Health Services Queensland Human Research Ethics Committee
Ethics committee address [2] 294049 0
Level 3, RCH Foundation Building
Royal Children's Hospital
Herston QLD 4029
Ethics committee country [2] 294049 0
Australia
Date submitted for ethics approval [2] 294049 0
28/08/2013
Approval date [2] 294049 0
16/12/2013
Ethics approval number [2] 294049 0
HREC/13/QRCH/185
Ethics committee name [3] 294050 0
Ethics review committee (RPAH zone)
Ethics committee address [3] 294050 0
Research Development Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [3] 294050 0
Australia
Date submitted for ethics approval [3] 294050 0
Approval date [3] 294050 0
25/07/2012
Ethics approval number [3] 294050 0
HREC/12/RPAH/337
Ethics committee name [4] 294051 0
Sir Charles Gairdner Group Human Reserach Ethics Committee
Ethics committee address [4] 294051 0
Level 2 A Block
Hospital Avenue
Nedlands WA 6009
Ethics committee country [4] 294051 0
Australia
Date submitted for ethics approval [4] 294051 0
Approval date [4] 294051 0
21/08/2013
Ethics approval number [4] 294051 0
2012-183 approval SCGOPHCG
Ethics committee name [5] 294052 0
Princess Margaret Human Research Ethics Committee
Ethics committee address [5] 294052 0
Princess Margaret Hospital
Roberts Road, Subiaco, Perth
Western Australia 6008
Ethics committee country [5] 294052 0
Australia
Date submitted for ethics approval [5] 294052 0
24/11/2014
Approval date [5] 294052 0
16/12/2014
Ethics approval number [5] 294052 0
2014105EP
Ethics committee name [6] 296754 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [6] 296754 0
St John of God Health Care Human Research Ethics Committee
C/o St John of God Subiaco Hospital
12 Salvado Road
Subiaco Western Australia 6008
Ethics committee country [6] 296754 0
Australia
Date submitted for ethics approval [6] 296754 0
05/08/2015
Approval date [6] 296754 0
12/08/2015
Ethics approval number [6] 296754 0
Ref No. 825
Ethics committee name [7] 303205 0
Griffith University Human Research Ethics Committee
Ethics committee address [7] 303205 0
Bray Centre (N54) 0.15
Office for Research
Griffith University, Nathan Campus
Nathan, Queensland, 4111
Ethics committee country [7] 303205 0
Australia
Date submitted for ethics approval [7] 303205 0
15/11/2010
Approval date [7] 303205 0
08/12/2010
Ethics approval number [7] 303205 0
NRS/27/10/HREC

Summary
Brief summary
IVD insertion is the most common invasive healthcare procedure with approximately 14 million IVDs used in Australia each year. IVDs alone are inadequate to deliver most therapy and require connection to an administration set. These IVD administration sets (AS) refer to infusion systems comprised of some or all of: tubing, fluid containers, pressure monitoring transducers, blood sampling ports, measuring burettes and extension tubing. IVDs and their AS break the natural defence barrier of the skin, and are the single most important cause of healthcare acquired blood stream infection (BSI). Most IVD's are replaced every 3 -4 days , however preliminary research suggests routine replacement of AS every 4 days costs Australia about $1 billion annually, and some studies suggest 7 day use would reduce costs with no threat to patient safety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31204 0
Prof Claire Rickard
Address 31204 0
School of Nursing and Midwifery
Griffith University Nathan Campus N48_2.12
Nathan QLD 4111
Country 31204 0
Australia
Phone 31204 0
+61 07 3735 6460
Fax 31204 0
Email 31204 0
[email protected]
Contact person for public queries
Name 14451 0
Ms Nicole Marsh, Project Manager
Address 14451 0
Royal Brisbane and Women's Hospital
Country 14451 0
Australia
Phone 14451 0
3636 8740
Fax 14451 0
Email 14451 0
[email protected]
Contact person for scientific queries
Name 5379 0
Prof Prof Claire Rickard
Address 5379 0
Griffith Universtiy
170 Kessels Road,
Nathan QLD 4111
Country 5379 0
Australia
Phone 5379 0
61 7 3735 6460
Fax 5379 0
Email 5379 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per HREC/IRB approved conditions, individual participant data will not be available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1824Study protocol    RSVP Trial Protocol 335526-(Uploaded-09-04-2019-12-06-27)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIntravascular device administration sets: Replacement after standard versus prolonged use in hospitalised patients - A study protocol for a randomised controlled trial (The RSVP Trial).2015https://dx.doi.org/10.1136/bmjopen-2014-007257
EmbaseIntravenous administration set (infusion tubing) replacement after 4 or 7 days is equally effective to prevent bloodstream infections (RSVP trial).2019https://dx.doi.org/10.1177/1129729818778929
EmbaseEffect of infusion set replacement intervals on catheter-related bloodstream infections (RSVP): a randomised, controlled, equivalence (central venous access device)-non-inferiority (peripheral arterial catheter) trial.2021https://dx.doi.org/10.1016/S0140-6736%2821%2900351-2
N.B. These documents automatically identified may not have been verified by the study sponsor.