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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral amiodarone, group A | Experimental | oral amiodarone 400 mg three times a day for 2 days |
|
| IV amiodarone, Group B | Experimental | Amiodarone: IV loading of 300 mg for 30 min in 100cc glucose 5% IV infusion with 900 mg/24h in 1000cc glucose 5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amiodarone | Drug | patients will be randomly assigned to oral OR IV Amiodarone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of phlebitis | 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 | during 24 h |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of hypotension | blood pressure measurements will be taken on admission and during treatment at defined intervals of 3, 6, 12, 18 and 24 h | during 24 h |
| Cumulative incidence of restored sinus rhythm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lilach Shema-didi, PhD | Contact | 972-507887538 | lilach.shema-didi@naharia.health.gov.il | |
| Atar Shaul, MD | Contact | 972-507887577 | Shaul.Atar@naharia.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Atar Shaul, MD | Western Galilee Hospital | Principal Investigator |
| Nicola Makhoul, MD | Western Galilee Hospital | Principal Investigator |
| Lilach Shema-didi, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Galilee Hospital | Nahariya | Israel | 972 | Israel |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D010689 | Phlebitis |
| D013924 | Thrombophlebitis |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Patients will be monitored during all stuffy period
| During 48h |
| Western Galilee Hospital |
| Principal Investigator |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D014657 | Vasculitis |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |