Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00103636
Recruitment Status : Unknown
Verified February 2005 by Royal Brisbane and Women's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 14, 2005
Last Update Posted : June 24, 2005
Information provided by:
Royal Brisbane and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Phlebitis Procedure: Extending peripheral intravenous (IV) cannula dwell times Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
Study Start Date : March 2004
Study Completion Date : December 2004

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

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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


  • They are scheduled or expected to have a peripheral venous catheter indwelling for at least 4 days.


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00103636

Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Sponsors and Collaborators
Royal Brisbane and Women's Hospital Identifier: NCT00103636     History of Changes
Other Study ID Numbers: RBWH 2003/131
First Posted: February 14, 2005    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 2005

Keywords provided by Royal Brisbane and Women's Hospital:
Intravenous/adverse effects
Randomised controlled trial
Time factors

Additional relevant MeSH terms:
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases