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Status unknownNCT00103636Updated Jun 24, 2005

Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change

A Phase 2/3 interventional study of Extending peripheral intravenous (IV) cannula dwell times in Phlebitis, sponsored by Royal Brisbane and Women's Hospital. Status unknown at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Royal Brisbane and Women's Hospital · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2005), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Phlebitis

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Keywords

  • Phlebitis/etiology
  • Infusions
  • Intravenous/adverse effects
  • Randomised controlled trial
  • Phlebitis/prevention
  • Adult
  • Time factors
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with an existing bloodstream infection
  • Those receiving immunosuppressive treatment
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants

Interventions

  • ProcedureExtending peripheral intravenous (IV) cannula dwell times
05

What researchers measure

Primary outcomes

  1. Phlebitis during the course of the infusion and up to 48 hours after peripheral venous catheter removal

Secondary outcomes

  1. Infiltration permeation of IV fluid into the interstitial compartment

  2. Local infection at the site of the catheter

  3. Catheter-related blood stream infection

  4. Catheter colonization

  5. Cost

06

Study locations

1 site
  • Royal Brisbane and Women's Hospital
    Brisbane, Queensland 4029, Australia
07

Registry details

Key details

Study ID
NCT00103636
Lead sponsor
Royal Brisbane and Women's Hospital
First posted
Feb 14, 2005
Start date
Mar 2004
Completion
Dec 2004
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2005. You cannot join it, but the record below documents what was studied.

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