Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000421336
Ethics application status
Approved
Date submitted
5/08/2008
Date registered
25/08/2008
Date last updated
24/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial of routine replacement of peripheral cannulae versus removal on clinical indication
Scientific title
Randomised controlled trial of routine replacement of peripheral cannulae versus removal on clinical indication for the prevention of phlebitis
Secondary ID [1] 283449 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phlebitis associated with intravenous cannulation 3510 0
Condition category
Condition code
Infection 3664 3664 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Generic hospital patients from medical/surgical/oncology wards with a peripheral intravenous device (IV) will have this used for 72-96 hours. The IV will then be removed and a new IV will be inserted into a different vein. This will continue for the course of treatment (e.g. the course of antibiotics or rehydration).
Intervention code [1] 3229 0
Prevention
Comparator / control treatment
Intravenous cannulae (IVs) are left in situ unless clinically indicated for removal (phlebitis, suspected infection, malfunction, tretament ceased). The IV is used for the course of treatment (e.g. course of antibiotics). There is no prescribed duration of IV dwell time.
Control group
Active

Outcomes
Primary outcome [1] 4568 0
Phlebitis: Phlebitis during catheterisation or up to 48 hours after catheter removal. Phlebitis defined as 2 or more of: pain, tenderness, erythema, swelling, purulence, and/or palpable venous cord.
Timepoint [1] 4568 0
Daily whilst cannulae is in situ
Secondary outcome [1] 7721 0
Catheter Related Bloodstream Infection (CRBSI): Bacteremia/fungemia with 1 positive blood culture obtained from a peripheral vein, clinical manifestations of infections (i.e.fever, chills, and/or hypotension), and no apparent source for the BSI except the catheter. One of the following should be present: a positive semiquantitative (>15 CFU/catheter segment) or quantitative (>103 Colony Forming Units/catheter segment catheter)
culture whereby the same organism (species and antibiogram) is isolated from the catheter segment and peripheral blood; simultaneous quantitative blood cultures with a >5:1 ratio IV versus peripheral; differential period of IV culture versus peripheral blood culture positivity of >2 hours.
Timepoint [1] 7721 0
Daily whilst cannulae in situ

Eligibility
Key inclusion criteria
Peripheral cannulae in situ as part of routine clinical care for 3 days, written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current bloodstream infection, immunosuppressed, planned intravenous device (IV) removal within 24 hours

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)
Study group is concealed until randomisation. A telephone service is used to conceal.
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
1/02/2007
Actual
20/05/2008
Date of last participant enrolment
Anticipated
Actual
9/09/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
754
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1615 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 7497 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 3683 0
Charities/Societies/Foundations
Name [1] 3683 0
Clifford Craig Medical Research Trust
Country [1] 3683 0
Australia
Funding source category [2] 3684 0
Hospital
Name [2] 3684 0
Launceston General Hospital
Country [2] 3684 0
Australia
Funding source category [3] 3685 0
University
Name [3] 3685 0
University of Tasmania
Country [3] 3685 0
Australia
Funding source category [4] 3686 0
University
Name [4] 3686 0
Griffith University
Country [4] 3686 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Research Centre for Clinical and Community Practice Innovation
Nathan Campus, Kessels Road QLD 4111
Country
Australia
Secondary sponsor category [1] 3307 0
None
Name [1] 3307 0
Address [1] 3307 0
Country [1] 3307 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5736 0
Tasmanian State Research Ethics Committee
Ethics committee address [1] 5736 0
Ethics committee country [1] 5736 0
Australia
Date submitted for ethics approval [1] 5736 0
Approval date [1] 5736 0
18/12/2006
Ethics approval number [1] 5736 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28810 0
Prof Claire Rickard
Address 28810 0
Griffith University 170 Kessels Road Nathan QLD 4111
Country 28810 0
Australia
Phone 28810 0
+61 7 3735 6460
Fax 28810 0
Email 28810 0
[email protected]
Contact person for public queries
Name 11967 0
Prof Claire Rickard
Address 11967 0
Griffith University
170 Kessels Rd, Nathan QLD 4111
Country 11967 0
Australia
Phone 11967 0
07 3735 6460
Fax 11967 0
Email 11967 0
[email protected]
Contact person for scientific queries
Name 2895 0
Prof Claire Rickard
Address 2895 0
Griffith University
170 Kessels Road Nathan QLD 4111
Country 2895 0
Australia
Phone 2895 0
07 3735 6460
Fax 2895 0
Email 2895 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRoutine resite of peripheral intravenous devices every 3 days did not reduce complications compared with clinically indicated resite: A randomised controlled trial.2010https://dx.doi.org/10.1186/1741-7015-8-53
N.B. These documents automatically identified may not have been verified by the study sponsor.