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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
Secondary ID [1] 0 0
RBWH 2003/131
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phlebitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phlebitis during the course of the infusion and up to 48 hours after peripheral venous catheter removal
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Infiltration permeation of IV fluid into the interstitial compartment
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Local infection at the site of the catheter
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Catheter-related blood stream infection
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Catheter colonization
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Cost
Timepoint [5] 0 0

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with an existing bloodstream infection
* Those receiving immunosuppressive 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Government body
Name
Royal Brisbane and Women's Hospital
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00103636