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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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
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

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Current bloodstream infection, immunosuppressed, planned intravenous device (IV) removal within 24 hours

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Name [1] 3683 0
Clifford Craig Medical Research Trust
Address [1] 3683 0
PO Box 1963
Launceston TAS 7250
Country [1] 3683 0
Funding source category [2] 3684 0
Name [2] 3684 0
Launceston General Hospital
Address [2] 3684 0
Charles St.
Launceston TAS 7250
Country [2] 3684 0
Funding source category [3] 3685 0
Name [3] 3685 0
University of Tasmania
Address [3] 3685 0
Newnham Campus, Tas 7250
Country [3] 3685 0
Funding source category [4] 3686 0
Name [4] 3686 0
Griffith University
Address [4] 3686 0
Nathan Campus QLD 4111
Country [4] 3686 0
Primary sponsor type
Griffith University
Research Centre for Clinical and Community Practice Innovation
Nathan Campus, Kessels Road QLD 4111
Secondary sponsor category [1] 3307 0
Name [1] 3307 0
Address [1] 3307 0
Country [1] 3307 0

Ethics approval
Ethics application status
Ethics committee name [1] 5736 0
Tasmanian State Research Ethics Committee
Ethics committee address [1] 5736 0
Uni of Tasmania, Sandy Bay Campus
Hobart 7000 TAS
Ethics committee country [1] 5736 0
Date submitted for ethics approval [1] 5736 0
Approval date [1] 5736 0
Ethics approval number [1] 5736 0

Brief summary
In Australia each year ten million intravenous (IV) drips are inserted in patients’ arms or in the backs of their hands to give fluid and medications.
Many drips are routinely replaced every few days in the hope that this reduces infection, however preliminary research suggests it would be better and more cost effective to leave them alone. That would save patients the pain of another needle as well as interruption to treatment. It would save doctors and nurses time, and reduce waste from plastic disposables. The research will provide the evidence to know one way or the other whether IV drips should be routinely changed or left alone.
Trial website
Trial related presentations / publications
Public notes

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

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary