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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01817439
Recruitment Status : Unknown
Verified March 2013 by lilach shema, Western Galilee Hospital-Nahariya.
Recruitment status was:  Not yet recruiting
First Posted : March 25, 2013
Last Update Posted : March 25, 2013
Information provided by (Responsible Party):
lilach shema, Western Galilee Hospital-Nahariya

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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Amiodarone Phase 3

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  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Intravenous vs. Oral Administration of Amiodarone on the Incidence Rate of Phlebitis Among Patients With Recent Onset of Atrial Fibrillation (AF)
Study Start Date : May 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

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 Name: Procor

Experimental: IV amiodarone, Group B


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 Name: Procor

Primary Outcome Measures :
  1. Incidence rate of phlebitis [ Time Frame: during 24 h ]
    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

Secondary Outcome Measures :
  1. incidence of hypotension [ Time Frame: during 24 h ]
    blood pressure measurements will be taken on admission and during treatment at defined intervals of 3, 6, 12, 18 and 24 h

  2. Cumulative incidence of restored sinus rhythm [ Time Frame: During 48h ]
    Patients will be monitored during all stuffy period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01817439

Contact: Lilach Shema-didi, PhD 972-507887538
Contact: Atar Shaul, MD 972-507887577

Western Galilee Hospital Not yet recruiting
Naharia, Israel, 972
Contact: Lilach Shema-didi, PhD    507887538 ext 972   
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
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

Responsible Party: lilach shema, Coordinator, Quality Assurance Unit, Western Galilee Hospital-Nahariya Identifier: NCT01817439     History of Changes
Other Study ID Numbers: AP 1
First Posted: March 25, 2013    Key Record Dates
Last Update Posted: March 25, 2013
Last Verified: March 2013

Keywords provided by lilach shema, Western Galilee Hospital-Nahariya:
oral Amiodarone
IV Amiodarone
adverse events

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors