Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit

Atrial Fibrillation Clinical Trial

— AFIB  

Official title:

Atrial Fibrillation WITHOUT Hemodynamic Stability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461733
• Other study ID #: NA5936 Heart and Stroke
• Secondary ID: OHREB Protocol #
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2010
• Last updated: September 9, 2014
• Start date: July 2007
• Est. completion date: December 2009

Study information

• Verified date: September 2014
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence that resolves as the patient recovers from their underlying condition. However, patients who develop AF can present with a very rapid heart rate that in some cases can put stress on the heart which can lead to life threatening heart attacks, low blood pressure or breathing problems. Not all patients with AF will have unstable heart function but those who have rapid heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no unstable heart function are two fold. Patients can be treated by controlling the heart rate and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be controlled by medication and the AF can be converted by either electrical cardioversion (an electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal of treatment should be to simply control the heart rate and wait for the patient to spontaneously convert to a normal heart rhythm or convert the AF with medication for patients who only have the rapid heart rate.

The objective of this project is to conduct a pilot study to determine if it would be feasible to conduct a larger definitive trial that would answer the following question: Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart rhythm in patients with AF who have a rapid heart rate without unstable heart function.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• new onset afib

Exclusion Criteria:

• hemodynamically unstable

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• amiodarone
standard dose amiodarone
• Placebo
placebo delivered blinded

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Heart and Stroke Foundation of Ontario

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion From Atrial Fibrillation to Sinus Rhythm	Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.	From randomization to conversion or ICU discharge up to 100 months.	Yes