Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2005 by Royal Brisbane and Women's Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Royal Brisbane and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00103636
First received: February 11, 2005
Last updated: June 23, 2005
Last verified: February 2005
  Purpose

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 Intervention Phase
Phlebitis
Procedure: Extending peripheral intravenous (IV) cannula dwell times
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change

Further study details as provided by Royal Brisbane and Women's Hospital:

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

Estimated Enrollment: 200
Study Start Date: March 2004
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103636

Locations
Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Sponsors and Collaborators
Royal Brisbane and Women's Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00103636     History of Changes
Other Study ID Numbers: RBWH 2003/131
Study First Received: February 11, 2005
Last Updated: June 23, 2005
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

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

ClinicalTrials.gov processed this record on July 26, 2014