Repeated Amiodarone Dosing In Cardiac surgicaL Procedures

NCT05004077 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 67919
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, prospective, randomized, open-label trial of subjects who develop atrial fibrillation after non-emergent cardiac surgery at the University of Kentucky Chandler Medical Center (UKCMC). Patients will be randomized to receive either a conventional amiodarone dosing regimen (CDR) or a repeated amiodarone bolus dosing regimen (RBDR).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Normal Sinus Rhythm -24 HRS

  Percentage of patients who develop stable POAF after non-emergent cardiac surgery, the percentage of patients who have converted to NSR at 24-hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have converted to NSR after a conventional amiodarone IV loading dose regimen.

  24-hours after receiving amiodarone bolus

Secondary Outcomes (4)

• Total Target Heart Rate Time

  24-hours after receiving amiodarone bolus

• Time to Target Heart Rate

  24-hours after receiving amiodarone bolus

• Normal Sinus Rhythm -Hospital Index

  duration of ICU and hospital visit, up to 20 days

• Recurrent AF

  duration of ICU and hospital visit, up to 20 days

Study Arms (2)

Conventional amiodarone dosing regimen (CDR)

ACTIVE COMPARATOR

Initial amiodarone bolus of 150 mg IV over 10 minutes then a 24-hour amiodarone loading infusion (1 mg/min for 6 hours followed by 0.5 mg/min for 18 hours), followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician.

Drug: AMIODARONE

Repeated amiodarone bolus dosing regimen (RBDR)

ACTIVE COMPARATOR

Initial amiodarone bolus of 150 mg IV over 10 minutes, then 1.0 mg/min IV amiodarone infusion for 6 hours, then a 0.5 mg/min IV amiodarone infusion for 18 hours, followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. In addition, patients in the RBDR will receive an additional 150 mg IV amiodarone bolus whenever the patient develops tachycardia (Heart Rate (HR) = 110 beats per minute) lasting more than 10 minutes. This bolus may be repeated up to a total of 5 times (6 total boluses) over the first 24 hours. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician.

Drug: AMIODARONE

Interventions

AMIODARONE DRUG

Assess the effectiveness of different dosing strategies of amiodarone.

Conventional amiodarone dosing regimen (CDR); Repeated amiodarone bolus dosing regimen (RBDR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be 18 years old or older
• Subject must be willing to give written informed consent
• Subject must undergo or scheduled for non-emergent cardiac surgery, including coronary artery bypass grafting (CABG), non-infectious valve repair or replacement, atrial or septal defect repair, thoracic aortic replacement surgery, or any combination of these procedures

You may not qualify if:

• Documented allergy to amiodarone or iodine
• History of atrial fibrillation or other heart conduction system abnormality
• History of cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
• Scheduled cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
• Low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support
• History of pre-existing respiratory system disease requiring oxygen therapy prior to admission
• History of cirrhosis or other chronic liver diseases
• Pregnancy or breastfeeding mothers
• Prisoner status

Sponsors & Collaborators

• Kevin W Hatton, MD, PhD: lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Kevin Hatton
• Organization: University of Kentucky

kevin.hatton@uky.edu

859-218-0365

Study Officials

• Kevin Hatton, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Dept of Anesthesiology

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 13, 2021
• Study Start: November 2, 2021
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)