Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change

NCT ID: NCT00103636

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Phlebitis

Keywords

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Phlebitis/etiology Infusions Intravenous/adverse effects Randomised controlled trial Phlebitis/prevention Adult Time factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Extending peripheral intravenous (IV) cannula dwell times

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Brisbane and Women's Hospital

OTHER_GOV

Sponsor Role lead

Locations

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Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Site Status

Countries

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Australia

Other Identifiers

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RBWH 2003/131

Identifier Type: -

Identifier Source: org_study_id