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

Atrial Fibrillation Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01817439
• Other study ID #: AP 1
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 18, 2013
• Last updated: March 22, 2013
• Start date: May 2013
• Est. completion date: May 2015

Study information

• Verified date: March 2013
• Source: Western Galilee Hospital-Nahariya
• Contact: Lilach Shema-didi, PhD
• Phone: 972-507887538
• Email: lilach.shema-didi[@]naharia.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Amiodarone
patients will be randomly assigned to oral OR IV Amiodarone

Locations

Country	Name	City	State
Israel	Western Galilee Hospital	Naharia

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Cumulative incidence of restored sinus rhythm	Patients will be monitored during all stuffy period	During 48h	No