Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
Primary Purpose
Phlebitis
Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Extending peripheral intravenous (IV) cannula dwell times
Sponsored by
About this trial
This is an interventional treatment trial for Phlebitis focused on measuring Phlebitis/etiology, Infusions, Intravenous/adverse effects, Randomised controlled trial, Phlebitis/prevention, Adult, Time factors
Eligibility Criteria
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
Sites / Locations
- Royal Brisbane and Women's Hospital
Outcomes
Primary Outcome Measures
Phlebitis during the course of the infusion and up to 48 hours after peripheral venous catheter removal
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00103636
First Posted
February 11, 2005
Last Updated
June 23, 2005
Sponsor
Royal Brisbane and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00103636
Brief Title
Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
Official Title
Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
Study Type
Interventional
2. Study Status
Record Verification Date
February 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Brisbane and Women's Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phlebitis
Keywords
Phlebitis/etiology, Infusions, Intravenous/adverse effects, Randomised controlled trial, Phlebitis/prevention, Adult, Time factors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Extending peripheral intravenous (IV) cannula dwell times
Primary Outcome Measure Information:
Title
Phlebitis during the course of the infusion and up to 48 hours after peripheral venous catheter removal
Secondary Outcome Measure Information:
Title
Infiltration permeation of IV fluid into the interstitial compartment
Title
Local infection at the site of the catheter
Title
Catheter-related blood stream infection
Title
Catheter colonization
Title
Cost
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
12. IPD Sharing Statement
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Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
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