Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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