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Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit (AFIB)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
amiodarone
Placebo
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, amiodarone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • new onset afib

Exclusion Criteria:

  • hemodynamically unstable

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    amiodarone

    placebo

    Arm Description

    standard dose amiodarone

    Outcomes

    Primary Outcome Measures

    Conversion From Atrial Fibrillation to Sinus Rhythm
    Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 19, 2010
    Last Updated
    September 9, 2014
    Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    Heart and Stroke Foundation of Ontario
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01461733
    Brief Title
    Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit
    Acronym
    AFIB
    Official Title
    Atrial Fibrillation WITHOUT Hemodynamic Stability
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    Heart and Stroke Foundation of Ontario

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation
    Keywords
    atrial fibrillation, amiodarone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    amiodarone
    Arm Type
    Experimental
    Arm Description
    standard dose amiodarone
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    amiodarone
    Other Intervention Name(s)
    non applicable
    Intervention Description
    standard dose amiodarone
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo delivered blinded
    Primary Outcome Measure Information:
    Title
    Conversion From Atrial Fibrillation to Sinus Rhythm
    Description
    Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.
    Time Frame
    From randomization to conversion or ICU discharge up to 100 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: new onset afib Exclusion Criteria: hemodynamically unstable
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Salmaan Kanji, MD
    Organizational Affiliation
    Ottawa Hospital Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit

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