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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Western Galilee Hospital-Nahariya
Sponsor:
Information provided by (Responsible Party):
lilach shema, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01817439
First received: March 18, 2013
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Drug: Amiodarone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • Incidence rate of phlebitis [ Time Frame: during 24 h ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • incidence of hypotension [ Time Frame: during 24 h ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: During 48h ] [ Designated as safety issue: No ]
    Patients will be monitored during all stuffy period


Estimated Enrollment: 104
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral amiodarone, group A
oral amiodarone 400 mg three times a day for 2 days
Drug: Amiodarone
patients will be randomly assigned to oral OR IV Amiodarone
Other Name: Procor
Experimental: IV amiodarone, Group B

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
patients will be randomly assigned to oral OR IV Amiodarone
Other Name: Procor

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817439

Contacts
Contact: Lilach Shema-didi, PhD 972-507887538 lilach.shema-didi@naharia.health.gov.il
Contact: Atar Shaul, MD 972-507887577 Shaul.Atar@naharia.health.gov.il

Locations
Israel
Western Galilee Hospital Not yet recruiting
Naharia, Israel, 972
Contact: Lilach Shema-didi, PhD    507887538 ext 972    lilach.shema-didi@naharia.health.gov.il   
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
Principal Investigator: Atar Shaul, MD Western Galilee Hospital
Principal Investigator: Nicola Makhoul, MD Western Galilee Hospital
Principal Investigator: Lilach Shema-didi, PhD Western Galilee Hospital
  More Information

No publications provided

Responsible Party: lilach shema, Coordinator, Quality Assurance Unit, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01817439     History of Changes
Other Study ID Numbers: AP 1
Study First Received: March 18, 2013
Last Updated: March 22, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Western Galilee Hospital-Nahariya:
oral Amiodarone
IV Amiodarone
phlebitis
thrombophlebitis
adverse events

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on September 18, 2014