Atrial Fibrillation
Conditions
Keywords
oral Amiodarone, IV Amiodarone, phlebitis, thrombophlebitis, adverse events
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.
Interventions
DRUGAmiodarone
patients will be randomly assigned to oral OR IV Amiodarone
Sponsors
Western Galilee Hospital-Nahariya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of phlebitis | 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
| Measure | Time frame | Description |
|---|---|---|
| incidence of hypotension | 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 | During 48h | Patients will be monitored during all stuffy period |
Countries
Israel
Contacts
Primary ContactLilach Shema-didi, PhD
Backup ContactAtar Shaul, MD
Outcome results
None listed