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Clinical Trials/NCT06262932
NCT06262932
Completed
Phase 4

Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response

Police General Hospital, Thailand1 site in 1 country24 target enrollmentMay 1, 2024
InterventionsAmiodarone

Overview

Phase
Phase 4
Intervention
Amiodarone
Conditions
Atrial Fibrillation
Sponsor
Police General Hospital, Thailand
Enrollment
24
Locations
1
Primary Endpoint
Heart rate
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen

  • Repeated dosing regimen
  • Standard dosing regimen
Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Police General Hospital, Thailand
Responsible Party
Principal Investigator
Principal Investigator

Chawit Lopimpisuth

Principal Investigator

Police General Hospital, Thailand

Eligibility Criteria

Inclusion Criteria

  • Age above 18 years old
  • Atrial fibrillation with rapid ventricular response patient (ventricular rate \> 110)

Exclusion Criteria

  • Baseline EKG Corrected QT interval (QTc) \< 500 msec
  • History of pulmonary fibrosis
  • History of Cirrhosis
  • Cardiac Index \<2.2 L/min/m2 or Cardiogenic shock
  • Unstable arrhythmia
  • Receive amiodarone within 3 months prior to present illness
  • Pregnancy
  • Amiodarone or Iodine allergy

Arms & Interventions

Repeated amiodarone bolus dosing regimen

An Initial 150 mg IV amiodarone bolus should be given over a 15-minute period. If the heart rate is still over 110 minutes after the initial treatment, provide an additional 150 mg IV amiodarone bolus over a 15-minute period. During the first 24 hours, this bolus may be administered up to three times in total. Within 24 hours of finishing the first bolus dosage, 900 mg of amiodarone will be administered intravenously.

Intervention: Amiodarone

Standard dosing regimen

An Initial 150 mg IV amiodarone bolus should be given over a 15-minute period, then a 24-hour amiodarone loading infusion 900 mg over 24 hours

Intervention: Amiodarone

Outcomes

Primary Outcomes

Heart rate

Time Frame: 6-hours after receiving amiodarone bolus

Percentage of patients who have Atrial fibrillation with rapid ventricular response, the percentage of patients who have heart rate below 110 bpms at 6 hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have heart rate below 110 bpms at 6 hour after a conventional amiodarone IV loading dose regimen

Secondary Outcomes

  • Heart rate(24-hours after receiving amiodarone bolus)
  • Major adverse cardiovascular events(30 days after receiving amiodarone bolus)
  • Phlebitis(24-hours after receiving amiodarone bolus)
  • Normal sinus rhythm at 24 hours(24-hours after receiving amiodarone bolus)
  • Changed in heart rate(24-hours after receiving amiodarone bolus)

Study Sites (1)

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