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

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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)

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 Summary:

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.


Sponsor: Western Galilee Hospital-Nahariya

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Western Galilee Hospital-Nahariya

Dates:
Date Received: March 18, 2013
Date Started: May 2013
Date Completion: May 2015
Last Updated: March 22, 2013
Last Verified: March 2013