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Clinical Trials/NCT05058053
NCT05058053
Completed
N/A

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

Saglik Bilimleri Universitesi1 site in 1 country100 target enrollmentMarch 1, 2020
ConditionsPhlebitis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Phlebitis
Sponsor
Saglik Bilimleri Universitesi
Enrollment
100
Locations
1
Primary Endpoint
the rate of development of phlebitis
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
March 1, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tulay Basak

Principal Investigator

Saglik Bilimleri Universitesi

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • the grade of phlebitis(24+2 hours)

Study Sites (1)

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