Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103636
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2005-02-11
Brief Title:
Peripheral Venous Catheter Trial 3 Day Versus No Routine Change
Sponsor:
Royal Brisbane and Womens Hospital
Organization:
Royal Brisbane and Womens Hospital
Study Overview
Official Title:
Peripheral Venous Catheter Trial 3 Day Versus No Routine Change
Status:
UNKNOWN
Status Verified Date:
2005-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 and 63 and a central venous catheter related bacteremia rate of approximately 30 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None