Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
|ClinicalTrials.gov Identifier: NCT00103636|
Recruitment Status : Unknown
Verified February 2005 by Royal Brisbane and Women's Hospital.
Recruitment status was: Active, not recruiting
First Posted : February 14, 2005
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|Phlebitis||Procedure: Extending peripheral intravenous (IV) cannula dwell times||Phase 2 Phase 3|
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.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change|
|Study Start Date :||March 2004|
|Estimated Study Completion Date :||December 2004|
- Phlebitis during the course of the infusion and up to 48 hours after peripheral venous catheter removal
- Infiltration permeation of IV fluid into the interstitial compartment
- Local infection at the site of the catheter
- Catheter-related blood stream infection
- Catheter colonization
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103636
|Royal Brisbane and Women's Hospital|
|Brisbane, Queensland, Australia, 4029|