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Completed

NCT Number: NCT05058053

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

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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Key information

Conditions

Phlebitis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases Vasculitis

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Cold Application

Other

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

Primary outcomes

  1. the rate of development of phlebitis

    Time frame: 24+2 hours

    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.

Secondary outcomes

  1. the grade of phlebitis

    Time frame: 24+2 hours

    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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

INVESTIGATION OF THE EFFECT OF COLD APPLICATION ON THE DEVELOPMENT OF PHLEBITIS IN PATIENTS RECEIVING INTRAVENOUS AMIODARONE TREATMENT. A RANDOMIZED OPEN-LABEL TRIAL

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2021
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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