Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2005 by Royal Brisbane and Women's Hospital.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Royal Brisbane and Women's Hospital

ClinicalTrials.gov Identifier:

NCT00103636

First received: February 11, 2005

Last updated: June 23, 2005

Last verified: February 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	February 11, 2005
Last Updated Date	June 23, 2005
Start Date ^ICMJE	March 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Phlebitis during the course of the infusion and up to 48 hours after peripheral venous catheter removal
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00103636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Infiltration permeation of IV fluid into the interstitial compartment Local infection at the site of the catheter Catheter-related blood stream infection Catheter colonization Cost
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
Official Title ^ICMJE	Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
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.
Detailed Description	Among hospitalized patients, intravenous therapy is the most common invasive procedure. It is associated with a phlebitis rate of between 1.1% and 63% and a central venous catheter related bacteremia rate of approximately 3.0%. Catheter related blood-stream infections have an attributable mortality rate of 12% to 25%. Factors thought to be associated with these complications include insertion techniques, catheter securement, type of catheter used, type of infusate and additives, post-insertion catheter care and length of time the catheter remains in place. Current Centers of Disease Control Guidelines provide direction for intravenous therapy management including a recommendation that peripheral intravenous catheters should be re-sited every 72-96 hours. Data underpinning the recommendation was collected in 1992, over a decade ago. Since that time, there have been improvements in catheter design and composition, and prospective surveillance studies have demonstrated the safety of longer dwell times. To date, these observations have not been validated in adults, using randomized controlled trial methodology. Re-siting intravenous cannulas causes discomfort to patients and has a high recurrent cost. The primary aim of the present study is to compare the rates of peripheral catheter-related blood stream infection, 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. Specific hypotheses: That changing intravenous peripheral catheters when indicated by clinical signs compared to changing intravenous catheters every 3 days reduces the incidence of intravenous catheter related morbidity.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Phlebitis
Intervention ^ICMJE	Procedure: Extending peripheral intravenous (IV) cannula dwell times
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	200
Completion Date	December 2004
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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 Exclusion Criteria: Patients with an existing bloodstream infection Those receiving immunosuppressive treatment
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Australia

Administrative Information
NCT Number ^ICMJE	NCT00103636
Other Study ID Numbers ^ICMJE	RBWH 2003/131
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Royal Brisbane and Women's Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Royal Brisbane and Women's Hospital
Verification Date	February 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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