ClinicalTrials.gg
CompletedNCT03351725IPICCSUpdated Mar 7, 2019

Peripheral Venous Catheter Colonization Study

An observational study in Catheters, Indwelling and Catheter-Related Infections, sponsored by Linkoeping University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-07.

Sponsored by Linkoeping University · Observational

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
337
Ages
18 Years and older
Sex
All
01

Study summary

Peripheral intravenous cannulas (PIVCs) are utilized in large scale in modern health care. Known complications due to a PIVC are phlebitis, thrombosis, bleeding, nerve damage and infection. PIVC-related infection causes morbidity, mortality and increased healthcare costs. PIVC-related infections can and should be prevented.

Indwell time is a known risk factor for PIVC-related infection. Another factor potentially influencing the risk of developing PIVC-related infection is what type of PIVC that is being used. Roughly there are two types of PIVCs. One with an open injection valve and another with a closed injection valve. The former being far more used in our hospital and the latter being suggested as lowering the risk of PIVC-related infection compared to the open one.

The investigators aim with this study is to evaluate the incidence of PIVC-colonization in 300 patients at our 500-bed secondary level hospital in Sweden, as a first step in trying to understand what healthcare-providers can improve regarding prevention of PIVC-related infections.

Read the detailed description

Background:

Peripheral intravenous cannulas (PIVCs) are utilized in large scale in modern health care. Known complications due to a PIVC are phlebitis, thrombosis, bleeding, nerve damage and infection. PIVC-related infection causes morbidity, mortality and increased healthcare costs. In an Australian study the investigators found the presence of a PIVC the most frequent cause (36%) of healthcare-associated Staphylococcus aureus bacteraemia during 2012. PIVC-related infections can and should be prevented.

Indwell time is a known risk factor for PIVC-related infection. Another factor potentially influencing the risk of developing PIVC-related infection is what type of PIVC that is being used. Roughly there are two types of PIVCs. One with an open injection valve and another with a closed injection valve. The former being far more used in Ryhov County Hospital, Sweden, and the latter being suggested as lowering the risk of PIVC-related infection compared to the open one.

In a systematic review from 2006 Maki et al report a point incidence of blood stream infections of 0,5 per 1000 catheter-days in PIVCs. In 2014 Hammarskjöld reported an incidence of 0,6 per 1000 catheter-days regarding central venous catheters (CVC). Maki et al concludes "..., infection control programs must strive to consistently apply essential control measures and preventive technologies with all types of intravascular devices." The investigators find there is a gap between the large scale utilization of PIVCs and the knowledge about PIVC-related infections and recommendations on how to prevent them. Hammarskjöld et al has done research on infections related to CVCs, subcutaneous venous ports and on arterial cannulas but not PIVCs.

The aim with this study is to evaluate the incidence of PIVC-colonization at Ryhov County Hospital, a 500-bed secondary level hospital in Sweden, as a first step in trying to understand what can be done to improve work regarding prevention of PIVC-related infections.

Materials and methods

Setting The hospital is a 500-bed general county hospital including most medical, oncological and surgical specialties except neurosurgery and cardiac surgery. No solid organ or stem cell transplantations are performed.

Patients Patients admitted to surgical, medical or infectious wards were regularly included by a specifically trained nurse from June 2016 until December 2017.

Inclusion criteria: Patients ≥ 18 years of age with a PIVC in situ for 48 hours or more informed verbally and in written and invited to take part in the study. Exclusion criteria: Patients \< 18 years of age.

Microbiological methods Intraluminal hub culturing from the two injection sites of the PIVC performed with sterile cotton-tipped applicators moistened with sterile sodium chloride 0,9 %. Swabs transported in Amies medium with charcoal. Identification performed by standard methods at our local microbiology laboratory (www.srga.org.accessed _ http:// www.srga.org.accessed/ _ January 1, 2007).

Statistics Descriptive. How many positive cultures and which type of microbes were found.

02

Conditions studied

  • Catheters, Indwelling
  • Catheter-Related Infections

Keywords

  • peripheral venous catheter
  • catheter colonization
03

In context

Catheter-Related Infections

112 studies on the registry are indexed under Catheter-Related Infections; 18 are open to participants now.

This study's enrollment of 337 is above the median of 175 across 22 observational studies indexed under Catheter-Related Infections.

Browse Catheter-Related Infections studies →

Lead sponsor

Linkoeping University is the lead sponsor of 193 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Setting The hospital is a 500-bed general county hospital including most medical, oncological and surgical specialties except neurosurgery and cardiac surgery. No solid organ or stem cell transplantations are performed. Patients Patients admitted to surgical, medical or infectious wards were regularly included by a specifically trained nurse from June 2016 until December 2017.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years or older hospitalized in Ryhov County Hosptial, Sweden, with perhiperal venous catheter in situ for 48 hours or more.

Exclusion criteria

Exclusion Criteria:

  • Under 18 years of age.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
337 participants (actual)
Patient registry
No

Groups and cohorts

  • Peripheral venous catheter indwell time more than 48 hours

    Device: peripheral venous catheter (PVC)

Interventions

  • Deviceperipheral venous catheter (PVC)

    No intervention is made only in situ swab from the PVC

06

What researchers measure

Primary outcomes

  1. Positive culture

    Swab from peripheral venous catheter (PVC) in situ on patient having had the PVC for 48 hours or more.

    Time frame: 2-7 days

07

Study locations

1 site
  • Ryhov County Hospital
    Jönköping, Småland 55305, Sweden
08

References and documents

Publications

  • Rhodes D, Cheng AC, McLellan S, Guerra P, Karanfilovska D, Aitchison S, Watson K, Bass P, Worth LJ. Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service. J Hosp Infect. 2016 Sep;94(1):86-91. doi: 10.1016/j.jhin.2016.05.020. Epub 2016 Jun 7. PubMed 27346623 ↗
  • Gonzalez Lopez JL, Arribi Vilela A, Fernandez del Palacio E, Olivares Corral J, Benedicto Marti C, Herrera Portal P. Indwell times, complications and costs of open vs closed safety peripheral intravenous catheters: a randomized study. J Hosp Infect. 2014 Feb;86(2):117-26. doi: 10.1016/j.jhin.2013.10.008. Epub 2013 Dec 1. PubMed 24373830 ↗
  • Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006 Sep;81(9):1159-71. doi: 10.4065/81.9.1159. PubMed 16970212 ↗
  • Hammarskjold F, Berg S, Hanberger H, Taxbro K, Malmvall BE. Sustained low incidence of central venous catheter-related infections over six years in a Swedish hospital with an active central venous catheter team. Am J Infect Control. 2014 Feb;42(2):122-8. doi: 10.1016/j.ajic.2013.09.023. PubMed 24485369 ↗
  • Mermel LA. Short-term Peripheral Venous Catheter-Related Bloodstream Infections: A Systematic Review. Clin Infect Dis. 2017 Oct 30;65(10):1757-1762. doi: 10.1093/cid/cix562. PubMed 29020252 ↗
  • Juhlin D, Hammarskjold F, Mernelius S, Taxbro K, Berg S. Microbiological colonization of peripheral venous catheters: a prospective observational study in a Swedish county hospital. Infect Prev Pract. 2021 Jun 7;3(3):100152. doi: 10.1016/j.infpip.2021.100152. eCollection 2021 Sep. PubMed 34458717 ↗

Individual participant data

Plan to share: No — No individual data, but the the data regarding positive Cultures and what type of microbia found will be official

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2016 to primary completion in Dec 2017, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2017
First posted
Nov 24, 2017
StartActual
Jun 2016
Primary completionActual
Dec 20, 2017
CompletionActual
Dec 20, 2017
Last update
Mar 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03351725
Responsible party
Boel Andersson Gäre (Professor, Linkoeping University) — Principal investigator
First posted
Nov 24, 2017
Start date
Jun 2016
Primary completion
Dec 20, 2017
Completion
Dec 20, 2017
Last update
Mar 7, 2019

Study contacts

Boel Andersson Gäre, Professor
principal investigator · Linkoeping University, Sweden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion