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

NCT01817439 | Unknown Phase 3

• 1 other identifier: AP 1
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation

Keywords

oral Amiodarone; IV Amiodarone; phlebitis; thrombophlebitis; adverse events

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• incidence of hypotension

  during 24 h

• Cumulative incidence of restored sinus rhythm

  During 48h

Study Arms (2)

oral amiodarone, group A

EXPERIMENTAL

oral amiodarone 400 mg three times a day for 2 days

Drug: Amiodarone

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%

Drug: Amiodarone

Interventions

Amiodarone DRUG

patients will be randomly assigned to oral OR IV Amiodarone

Also known as: Procor

IV amiodarone, Group B; oral amiodarone, group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age,
• Patients who will be admitted to the ICCU / ICU wards
• Patients with recent onset of atrial fibrillation (duration \< 48h).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Western Galilee Hospital

Nahariya, Israel, 972, Israel

Location

MeSH Terms

Conditions

Atrial Fibrillation; Phlebitis; Thrombophlebitis

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peripheral Vascular Diseases; Vascular Diseases; Vasculitis; Venous Thrombosis; Thrombosis; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Atar Shaul, MD

  Western Galilee Hospital

  PRINCIPAL INVESTIGATOR

• Nicola Makhoul, MD

  Western Galilee Hospital

  PRINCIPAL INVESTIGATOR

• Lilach Shema-didi, PhD

  Western Galilee Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator, Quality Assurance Unit

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 25, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 25, 2013

Record last verified: 2013-03

Locations

IL (1)