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

March 18, 2013
March 22, 2013
May 2013
May 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01817439 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Oral Versus Intravenous Amiodarone in the Treatment of AF
The Effect of Intravenous vs. Oral Administration of Amiodarone on the Incidence Rate of Phlebitis Among Patients With Recent Onset of Atrial Fibrillation (AF)

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
Drug: Amiodarone
patients will be randomly assigned to oral OR IV Amiodarone
Other Name: Procor
  • Experimental: oral amiodarone, group A
    oral amiodarone 400 mg three times a day for 2 days
    Intervention: Drug: Amiodarone
  • 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%

    Intervention: Drug: Amiodarone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
104
May 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
Israel
 
NCT01817439
AP 1
No
lilach shema, Western Galilee Hospital-Nahariya
Western Galilee Hospital-Nahariya
Not Provided
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
Western Galilee Hospital-Nahariya
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP