PhlebitisPhase 2/3NCT00103636
Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
A Phase 2/3 study testing Extending peripheral intravenous (IV) cannula dwell times in people with Phlebitis, run by Royal Brisbane and Women's Hospital at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phlebitis
- What is being tested?
- Extending peripheral intravenous (IV) cannula dwell times
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2004to Dec 2004
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with an existing bloodstream infection
- Those receiving immunosuppressive treatment
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
About this study
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.
- Conditions
- Phlebitis
- Being tested
- Extending peripheral intravenous (IV) cannula dwell times
- Keywords
- Phlebitis/etiology, Infusions, Intravenous/adverse effects, Randomised controlled trial, Phlebitis/prevention, Adult, Time factors
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extending peripheral intravenous (IV) cannula dwell timesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Phlebitis during the course of the infusion and up to 48 hours after peripheral venous catheter removal
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2005 (estimated)
- Study startMar 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhlebitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Royal Brisbane and Women's Hospital
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103636
- Sponsor's protocol ID
- RBWH 2003/131
- Status last verified
- Feb 2005
- First submitted
- 11 Feb 2005
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change
- ClinicalTrials.gov ID
- NCT00103636
- Acronym / sponsor ID
- RBWH 2003/131
- Conditions
- Phlebitis
- Keywords
- Phlebitis/etiology, Infusions, Intravenous/adverse effects, Randomised controlled trial, Phlebitis/prevention, Adult, Time factors
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Royal Brisbane and Women's HospitalOther government
- Study start
- Mar 2004
- Study completion
- Dec 2004
- First posted
- 14 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with an existing bloodstream infection
- Those receiving immunosuppressive treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extending peripheral intravenous (IV) cannula dwell times | Procedure or surgery | – |
Primary outcome
Phlebitis during the course of the infusion and up to 48 hours after peripheral venous catheter removal
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Extending peripheral intravenous (IV) cannula dwell times in people with Phlebitis, run by Royal Brisbane and Women's Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phlebitis during the course of the infusion and up to 48 hours after peripheral venous catheter removal. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.