ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Condition category

Condition code

Infection

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]

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]

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]

Daily whilst cannulae is in situ

Secondary outcome [1]

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]

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?

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]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Royal Brisbane Hospital

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Clifford Craig Medical Research Trust

Address [1]

PO Box 1963
Launceston TAS 7250

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Launceston General Hospital

Address [2]

Charles St.
Launceston TAS 7250

Country [2]

Australia

Funding source category [3]

University

Name [3]

University of Tasmania

Address [3]

Newnham Campus, Tas 7250

Country [3]

Australia

Funding source category [4]

University

Name [4]

Griffith University

Address [4]

Nathan Campus QLD 4111

Country [4]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmanian State Research Ethics Committee

Ethics committee address [1]

Uni of Tasmania, Sandy Bay Campus
Hobart 7000 TAS

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

18/12/2006

Ethics approval number [1]

Summary

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

Contacts

Principal investigator

Name

Prof Claire Rickard

Address

Griffith University 170 Kessels Road Nathan QLD 4111

Country

Australia

Phone

+61 7 3735 6460

Fax

c.rickard@griffith.edu.au

Contact person for public queries

Name

Prof Claire Rickard

Address

Griffith University
170 Kessels Rd, Nathan QLD 4111

Country

Australia

Phone

07 3735 6460

Fax

c.rickard@griffith.edu.au

Contact person for scientific queries

Name

Prof Claire Rickard

Address

Griffith University
170 Kessels Road Nathan QLD 4111

Country

Australia

Phone

07 3735 6460

Fax

c.rickard@griffith.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Routine resite of peripheral intravenous devices every 3 days did not reduce complications compared with clinically indicated resite: A randomised controlled trial.	2010	https://dx.doi.org/10.1186/1741-7015-8-53

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically