Clinical trial NCT01817439: Safety and Efficacy of Oral Versus Intravenous Amiodarone in the Treatment of AF
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: oral Amiodarone
IV Amiodarone
phlebitis
thrombophlebitis
adverse events
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2013-03-25
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence rate of phlebitis
timeFrame: during 24 h
Secondary outcomes:
measure: incidence of hypotension
timeFrame: during 24 h
measure: Cumulative incidence of restored sinus rhythm
timeFrame: During 48h
Other outcomes:
Locations:
city: Naharia
country: Israel
facility: Western Galilee Hospital
Study officials:
affiliation: Western Galilee Hospital
name: Atar Shaul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Galilee Hospital
name: Nicola Makhoul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Galilee Hospital
name: Lilach Shema-didi, PhD
role: PRINCIPAL_INVESTIGATOR
References: