Safety and Efficacy of Oral Versus Intravenous Amiodarone in the Treatment of AF

The Effect of Intravenous vs. Oral Administration of Amiodarone on the Incidence Rate of Phlebitis Among Patients With Recent Onset of Atrial Fibrillation (AF)

Atrial fibrillation (AF) remains a significant contributor to cardiovascular morbidity. Amiodarone is a potent antiarrhythmic drug; however, patients receiving IV amiodarone are at high risk for phlebitis. Phlebitis may lead to infection, additional medical intervention, delay in treatment, and prolonged hospitalization. Therefore, examining new therapy approach, aimed to reduce the incidence of phlebitis is a valuable clinical and research goal.

Aim: To evaluate the safety and efficacy of oral versus intravenous (IV) Amiodarone in the treatment of AF of recent onset (duration < 48 h).

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Amiodarone

Detailed Description

Atrial fibrillation (AF) is the most common heart rhythm abnormality worldwide. Three therapeutic goals should be considered for each patient: Rate control, maintenance of sinus rhythm and prevention of thromboembolism. In managing AF, numerous antiarrhythmic drugs have been used. Intravenous amiodarone is a class III antiarrhythmic agent which has been reported to be safe and most effective in various clinical settings, without an associated increase in mortality rate. In most of the cases, the method of administration is via peripheral infusion. Phlebitis is the most common complication with peripheral infusion of amiodarone. Phlebitis adversely affects patient care; it may interfere with the continued infusion of amiodarone, necessitate insertion of another peripheral intravenous or central catheter, and extend hospitalization. Furthermore, patients who develop phlebitis, experience pain, swelling, and inflammation. Phlebitis can be prevented by oral administration.

The goal of the proposed study is to evaluate the incidence rate of phlebitis following IV administration of amiodarone and to investigate whether the oral administration of amiodarone in patients with recent onset AF (duration < 48 h), is safer than, and as efficient as, the IV administration of the same drug in the ICCU and ICU setting.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Naharia, Israel, 972
    • Western Galilee Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over 18 years of age,
• Patients who will be admitted to the ICCU / ICU wards
• Patients with recent onset of atrial fibrillation (duration < 48h).

Exclusion Criteria:

• Age < 18 years
• Baseline systolic blood pressure < 100 mm/hg
• Known thyroid disease
• Serum potassium < 3.5 mmol/l
• Pretreatment with amiodarone
• Pregnant or lactating women.
• Participation in other clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral amiodarone, group A; oral amiodarone 400 mg three times a day for 2 days	Drug: Amiodarone; patients will be randomly assigned to oral OR IV Amiodarone; Other Names: Procor
Experimental: IV amiodarone, Group B; Amiodarone: IV loading of 300 mg for 30 min in 100cc glucose 5% IV infusion with 900 mg/24h in 1000cc glucose 5%	Drug: Amiodarone; patients will be randomly assigned to oral OR IV Amiodarone; Other Names: Procor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of phlebitis	For detection of eventual amiodarone induced phlebitis the site of venous access will be examined 30 min, 3, 6, 12, 24 h after drug administration by one of the investigators	during 24 h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of hypotension	blood pressure measurements will be taken on admission and during treatment at defined intervals of 3, 6, 12, 18 and 24 h	during 24 h
Cumulative incidence of restored sinus rhythm	Patients will be monitored during all stuffy period	During 48h

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya
• Investigators: Principal Investigator: Atar Shaul, MD, Western Galilee Hospital; Principal Investigator: Nicola Makhoul, MD, Western Galilee Hospital; Principal Investigator: Lilach Shema-didi, PhD, Western Galilee Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: March 18, 2013
• First Submitted That Met QC Criteria: March 22, 2013
• First Posted (Estimate): March 25, 2013

Study Record Updates

• Last Update Posted (Estimate): March 25, 2013
• Last Update Submitted That Met QC Criteria: March 22, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: adverse events; oral Amiodarone; IV Amiodarone; phlebitis; thrombophlebitis
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Amiodarone
• Other Study ID Numbers: AP 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No