Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit

NCT ID: NCT01461733

Last Updated: 2014-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-12-31

Brief 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.

Detailed Description

see above

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

amiodarone

standard dose amiodarone

Group Type: EXPERIMENTAL

amiodarone

Intervention Type: DRUG

standard dose amiodarone

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo delivered blinded

Interventions

amiodarone

standard dose amiodarone

Intervention Type: DRUG

Placebo

placebo delivered blinded

Intervention Type: DRUG

Other Intervention Names

non applicable

Eligibility Criteria

Inclusion Criteria

• new onset afib

Exclusion Criteria

• hemodynamically unstable

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

S. Kanji

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salmaan Kanji, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Other Identifiers

OHREB Protocol # 2006430-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NA5936 Heart and Stroke

Identifier Type: -

Identifier Source: org_study_id