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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00103636
Registration number
NCT00103636
Ethics application status
Date submitted
11/02/2005
Date registered
14/02/2005
Date last updated
24/06/2005
Titles & IDs
Public title
Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
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Scientific title
Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
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Secondary ID [1]
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RBWH 2003/131
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Phlebitis
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Extending peripheral intravenous (IV) cannula dwell times
Treatment: Surgery: Extending peripheral intravenous (IV) cannula dwell times
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phlebitis during the course of the infusion and up to 48 hours after peripheral venous catheter removal
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Infiltration permeation of IV fluid into the interstitial compartment
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Local infection at the site of the catheter
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Catheter-related blood stream infection
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Catheter colonization
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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Cost
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Assessment method [5]
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Timepoint [5]
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Eligibility
Key inclusion criteria
Patients are eligible to join the Peripheral Venous Catheter Trial if:
- They are inpatients at the Royal Brisbane and Royal Women's Hospital who are at least
18 years of age
AND
- They are scheduled or expected to have a peripheral venous catheter indwelling for at
least 4 days.
AND
- They have had their catheter inserted by a nurse from the IV Therapy Team
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients with an existing bloodstream infection
- Those receiving immunosuppressive treatment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment postcode(s) [1]
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4029 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
Royal Brisbane and Women's Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to investigate the effects of extending the dwell time of
peripheral intravenous cannulas on clinical outcomes and cost.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00103636
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00103636
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