Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change

Phlebitis Clinical Trial

Official title:

Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00103636
• Other study ID #: RBWH 2003/131
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: February 11, 2005
• Last updated: June 23, 2005
• Start date: March 2004
• Est. completion date: December 2004

Study information

• Verified date: February 2005
• Source: Royal Brisbane and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phlebitis

Intervention

Procedure:
• Extending peripheral intravenous (IV) cannula dwell times

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brisbane and Women's Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phlebitis during the course of the infusion and up to 48 hours after peripheral venous catheter removal
Secondary	Infiltration permeation of IV fluid into the interstitial compartment
Secondary	Local infection at the site of the catheter
Secondary	Catheter-related blood stream infection
Secondary	Catheter colonization
Secondary	Cost