Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000147684
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
15/08/2005
Date last updated
24/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The DRIP Trial
Scientific title
A randomised phase III study to evaluate the effects of changing peripheral intravenous cannulas when clinically indicated to reduce the rate of cannula related complications
Secondary ID [1] 280057 0
[email protected]
Universal Trial Number (UTN)
Trial acronym
The DRIP Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phlebitis and other adverse outcomes of peripheral venous cannulation. 237 0
Condition category
Condition code
Inflammatory and Immune System 268 268 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Cannula re-sited when clinically indicated
Intervention code [1] 164 0
Treatment: Devices
Comparator / control treatment
Control: Cannula re-sited every 3 days
Control group
Dose comparison

Outcomes
Primary outcome [1] 319 0
I/V related morbidity (using a composite measure of any reason for unplanned cannula removal)
Timepoint [1] 319 0
Catheter removal
Secondary outcome [1] 711 0
Cost
Timepoint [1] 711 0
At completion of trial

Eligibility
Key inclusion criteria
1. they are inpatients at the Royal Brisbane and Women's Hospital. 2. They are scheduled or expected to have a peripheral venous catheter indwelling for at least 4 days.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with an existing bloodstream infection 2. Those receiving immunosupressive treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central telephone
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
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
754
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 325 0
Government body
Name [1] 325 0
Queensland Nursing Council
Country [1] 325 0
Australia
Primary sponsor type
Individual
Name
Joan Webster
Address
RBWH
Butterfield St
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 256 0
None
Name [1] 256 0
None
Address [1] 256 0
Country [1] 256 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1247 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 1247 0
Ethics committee country [1] 1247 0
Australia
Date submitted for ethics approval [1] 1247 0
Approval date [1] 1247 0
Ethics approval number [1] 1247 0

Summary
Brief summary
Most hospitals re-site peripheral intravenous catheters in adults every 72-96 hours, based on current Centers of Disease Control and Prevention Guidelines. This is at odds with regimes for children, and critically ill patients, where cannulas are only re-sited when clinically indicated. Recent prospective surveillance studies have demonstrated the safety of longer dwell times but these observations have not been validated in adults, using randomised controlled trial methodology.
The primary aim of the present study is to compare the rates of peripheral catheter-related local infection, phlebitis and obstruction between two groups of patients - those having routine catheter changes every 72 hours and those having catheter changes only when clinically indicated.
Trial website
Trial related presentations / publications
Webster J, Clarke S, Paterson D, Hutton A, Van Dyk S, Gale C, Hopkins T. Peripheral intravenous catheters: randomized controlled trial of elective versus clinically indicated replacement. BMJ. 2008 Jul 8;337:a339. doi: 10.1136/bmj.a339
Public notes

Contacts
Principal investigator
Name 36331 0
Address 36331 0
Country 36331 0
Phone 36331 0
Fax 36331 0
Email 36331 0
Contact person for public queries
Name 9353 0
Joan Webster
Address 9353 0
Teaching and Research
Royal Brisbane and Women's Hospital
Level 6
Ned Hanlon Building
Herston QLD 4029
Country 9353 0
Australia
Phone 9353 0
+61 7 36368590
Fax 9353 0
+61 7 36362123
Email 9353 0
[email protected]
Contact person for scientific queries
Name 281 0
Joan Webster
Address 281 0
Teaching and Research
Royal Brisbane and Women's Hospital
Level 6
Ned Hanlon Building
Herston QLD 4029
Country 281 0
Australia
Phone 281 0
+61 7 36368590
Fax 281 0
+61 7 36362123
Email 281 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
No additional documents have been identified.