Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000445370
Ethics application status
Approved
Date submitted
5/08/2008
Date registered
5/09/2008
Date last updated
24/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Developing a research base for Intravenous Peripheral catheter resites: the DRIP Trial
Scientific title
Randomised Controlled Trial of routine versus clinically indicated resite of peripheral intravenous devices in hospitalised patients to prevent phlebitis
Secondary ID [1] 283448 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
phlebitis 3511 0
Condition category
Condition code
Infection 3665 3665 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in this study are generic medical/surgical/oncology hospitalised patients who require a peripheral intravenous device. Patients will have their peripheral intravenous devices (IVs) removed after 72-96 hours of use a new IV resited in another vein. This will continue for the course of IV therapy, that is as long as IV therapy is required.
Intervention code [1] 3230 0
Prevention
Comparator / control treatment
Patients will have their intravenous devices (IVs) left in situ for as long as treatment continues unless they have phlebitis or IV malfunction. The overall duration is for the course of treatment with an IV e.g. for a course of antibiotics or rehydration.
Control group
Active

Outcomes
Primary outcome [1] 4569 0
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] 4569 0
Daily while cannulae is in situ and for 48 hours post removal
Secondary outcome [1] 7722 0
Catheter related bloodstream infection: Bacteremia/fungemia with more than 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 colony forming units(CFU) /catheter segment) or quantitative (>103 CFU/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] 7722 0
Daily while cannulae is in situ or for 48 hours post removal

Eligibility
Key inclusion criteria
Scheduled or expected to have a peripheral IV in situ for 4 days or more, written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
current bacteraemia, planned removal of IV within 24 hours, IV already in situ for more than 48hrs

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
1/06/2008
Actual
20/05/2008
Date of last participant enrolment
Anticipated
Actual
9/10/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
3300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1614 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 7496 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 3687 0
Government body
Name [1] 3687 0
National Health and Medical Research Council (NHMRC)
Country [1] 3687 0
Australia
Funding source category [2] 3688 0
Hospital
Name [2] 3688 0
Royal Brisbane and Women's Hospital
Country [2] 3688 0
Australia
Funding source category [3] 3689 0
Hospital
Name [3] 3689 0
Princess Alexandra Hospital
Country [3] 3689 0
Australia
Funding source category [4] 3690 0
Hospital
Name [4] 3690 0
Gold Coast Hospital
Country [4] 3690 0
Australia
Funding source category [5] 3691 0
University
Name [5] 3691 0
Griffith University
Country [5] 3691 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Research Centre for Clinical and Community Practice Innovation, Nathan Campus 170 Kessels Road Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 3308 0
None
Name [1] 3308 0
Address [1] 3308 0
Country [1] 3308 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5737 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 5737 0
Ethics committee country [1] 5737 0
Australia
Date submitted for ethics approval [1] 5737 0
Approval date [1] 5737 0
10/12/2007
Ethics approval number [1] 5737 0
2007/186

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

Contacts
Principal investigator
Name 28811 0
Prof Claire Rickard
Address 28811 0
Griffith University 170 Kessels Road, Nathan QLD 4111
Country 28811 0
Australia
Phone 28811 0
+61 7 3735 6460
Fax 28811 0
Email 28811 0
[email protected]
Contact person for public queries
Name 11968 0
Prof Claire Rickard
Address 11968 0
Griffith University
170 Kessels Road, Nathan QLD 4111
Country 11968 0
Australia
Phone 11968 0
07 3735 6460
Fax 11968 0
Email 11968 0
[email protected]
Contact person for scientific queries
Name 2896 0
Prof Claire Rickard
Address 2896 0
Griffith University
Nathan Campus
170 Kessels Road
Nathan QLD 4111
Country 2896 0
Australia
Phone 2896 0
07 3735 6460
Fax 2896 0
Email 2896 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
Dimensions AIRisk Factors for Peripheral Intravenous Catheter Failure: A Multivariate Analysis of Data from a Randomized Controlled Trial2014https://doi.org/10.1086/674398
N.B. These documents automatically identified may not have been verified by the study sponsor.