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

NCT ID: NCT01817439

Last Updated: 2013-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-05-31

Brief Summary

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).

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

oral amiodarone, group A

oral amiodarone 400 mg three times a day for 2 days

Group Type: EXPERIMENTAL

Amiodarone

Intervention Type: DRUG

patients will be randomly assigned to oral OR IV Amiodarone

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%

Group Type: EXPERIMENTAL

Amiodarone

Intervention Type: DRUG

patients will be randomly assigned to oral OR IV Amiodarone

Interventions

Amiodarone

patients will be randomly assigned to oral OR IV Amiodarone

Intervention Type: DRUG

Other Intervention Names

Procor

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

lilach shema

Coordinator, Quality Assurance Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atar Shaul, MD

Role: PRINCIPAL_INVESTIGATOR

Western Galilee Hospital

Nicola Makhoul, MD

Role: PRINCIPAL_INVESTIGATOR

Western Galilee Hospital

Lilach Shema-didi, PhD

Role: PRINCIPAL_INVESTIGATOR

Western Galilee Hospital

Locations

Western Galilee Hospital

Nahariya, Israel, Israel

Countries

Israel

Central Contacts

Lilach Shema-didi, PhD

Role: CONTACT

lilach.shema-didi@naharia.health.gov.il

972-507887538

Atar Shaul, MD

Role: CONTACT

Shaul.Atar@naharia.health.gov.il

972-507887577

Facility Contacts

Lilach Shema-didi, PhD

Role: primary

lilach.shema-didi@naharia.health.gov.il

507887538 ext. 972

Other Identifiers

AP 1

Identifier Type: -

Identifier Source: org_study_id