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CompletedNCT05058053Updated Apr 17, 2024

THE EFFECT OF COLD APPLICATION ON THE DEVELOPMENT OF PHLEBITIS IN PATIENTS RECEIVING INTRAVENOUS AMIODARONE TREATMENT.

An interventional study of Cold application in Phlebitis, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Mar 2020, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 95 Years
Sex
All
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Study summary

This study, which has a quasi-experimental, prospective, and open-label randomized controlled design, was conducted to examine the effect of cold application on the development of phlebitis in patients receiving IV amiodarone infusion treatment.

Study Hypotheses H0-1: There is no difference in the rate of development of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.

H0-2: There is no difference in the grade of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.

H0-3: There is no difference in the time of development of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.

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Conditions studied

  • Phlebitis

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03

In context

Phlebitis

42 studies on the registry are indexed under Phlebitis; 9 are open to participants now.

This study's enrollment of 100 is below the median of 147 across 35 interventional studies indexed under Phlebitis.

Browse Phlebitis studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 447 studies on the registry; 138 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Patients aged over 18, who were planned to receive 300 mg amiodarone in 150 ccs of 5% dextrose + 900 mg amiodarone (maintenance) in 50 ccs of 5% Dextrose in 30 minutes (24 hour-infusion),
  • Patients to whom PVC was placed in the upper extremity, and who did not develop phlebitis on the PVC site

Exclusion criteria

Exclusion Criteria:

  • Cold allergy/sensitivity or circulatory disorders
  • During the study, patients who had a change in the IV amiodarone treatment protocol, whose IV amiodarone treatment was terminated before 24 hours, whose IV amiodarone treatment protocol was started, but PVC had to be replaced for any reason during the 24-hour period
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Cold application group

    After starting amiodarone treatment, cold application was applied a total of 12 times on the infused PVC with cold gel packs for 15 minutes at 2-hour intervals. At all stages of the study, the researcher closely monitored the patients. During the treatment, the development of phlebitis after cold application during the 24-hour infusion was evaluated every 2 hours by the researcher using the "Visual Infusion Phlebitis Scale" and recorded. After starting the amiodarone infusion, the patients were observed for the development of phlebitis for 24 hours until the end of the procedure and for 2 hours after the end of the treatment.

    Other: Cold application

  • No intervention
    Control group

    the patients who were started on amiodarone infusion were observed for the development of phlebitis, receiving no intervention. During the treatment, phlebitis development was evaluated and recorded by the researcher using the "Visual Infusion Phlebitis Scale" every 2 hours during the 24-hour infusion. After starting the amiodarone infusion, the patients were observed for the development of phlebitis for 24 hours until the end of the procedure and for 2 hours after the end of the treatment.

Interventions

  • OtherCold application

    Cold application was applied a total of 12 times on the infused PVC with cold gel packs for 15 minutes at 2-hour intervals.

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What researchers measure

Primary outcomes

  1. the rate of development of phlebitis

    the patients were observed for the development of phlebitis for 24 hours until the end of the procedure and for 2 hours after the end of the treatment.During the treatment, the development of phlebitis after cold application during the 24-hour infusion was evaluated every 2 hours by the researcher using the "Visual Infusion Phlebitis Scale" and recorded.

    Time frame: 24+2 hours

Secondary outcomes

  1. the grade of phlebitis

    the patients were observed for the development of phlebitis for 24 hours until the end of the procedure and for 2 hours after the end of the treatment.During the treatment, the development of phlebitis after cold application during the 24-hour infusion was evaluated every 2 hours by the researcher using the "Visual Infusion Phlebitis Scale" and recorded.

    Time frame: 24+2 hours

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Study locations

1 site
  • Gulhane Training and Research Hospital
    Ankara, 06010, Turkey (Türkiye)
08

References and documents

Publications

  • Okyay B, Basak T. The effect of cold gel pack application in the prevention of amiodarone-related phlebitis. Nurs Crit Care. 2024 Nov;29(6):1739-1743. doi: 10.1111/nicc.13020. Epub 2024 Jan 30. PubMed 38290741 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2020 to primary completion in Mar 2021, 12 months.

Of 20 interventional studies with no phase under Phlebitis, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's 12 months is above that.

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

Registered
Sep 7, 2021
First posted
Sep 27, 2021
StartActual
Mar 1, 2020
Primary completionActual
Mar 1, 2021
CompletionActual
Mar 1, 2021
Last update
Apr 17, 2024
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 Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05058053
Responsible party
Tulay Basak (Principal Investigator, Saglik Bilimleri Universitesi) — Principal investigator
First posted
Sep 27, 2021
Start date
Mar 1, 2020
Primary completion
Mar 1, 2021
Completion
Mar 1, 2021
Last update
Apr 17, 2024

Oversight

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

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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