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Rapid Atrial Fibrillation Treatment Strategy (RAFTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04092621
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Information provided by (Responsible Party):
Hollis O Neal, Our Lady of the Lake Regional Medical Center

Brief Summary:
Prospective, randomized, open-label clinical trial studying the treatment of new onset atrial fibrillation in critically ill patients with septic shock. Patients will be assigned to rhythm vs rate control strategies with various outcome measures assessed.

Condition or disease Intervention/treatment Phase
New Onset Atrial Fibrillation Sepsis Respiratory Failure Drug: Amiodarone in Parenteral Dosage Form Drug: Amiodarone Pill Procedure: Direct Current Cardioversion (DCC) Drug: Rate-control therapy Phase 4

Detailed Description:
Data have demonstrated that critically ill patients with septic shock who develop atrial fibrillation suffer a greater likelihood of death and other complications when compared with patients who remain in sinus rhythm, however, little evidence exists to inform treatment strategies in this population. Ours is a pilot study evaluating rhythm vs rate control strategies in patients with septic shock and respiratory failure requiring invasive mechanical ventilation who develop new onset atrial fibrillation (NOAF). Design will be prospective, randomized, open-label. Patients in the rhythm control arm will receive IV amiodarone infusion followed by attempt at electrical cardioversion within 24 hours development of NOAF. Those in the rate control arm will receive negative chronotropic agents (beta blockers, calcium channel blockers, amiodarone, or digoxin) at the discretion of the treating physician. Available patient data will be collected for a total of 180 days following enrollment, and outcomes assessed will include ICU length of stay, ventilator free days, and time on vasopressors

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rapid Atrial Fibrillation Treatment Strategy
Estimated Study Start Date : September 16, 2019
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Rhythm-control strategy
The patient will receive 1) amiodarone 150mg bolus over ten minutes followed by intravenous (IV) 1mg/min for 6 hours and then 0.5mg/min for 18hours, and 2) direct current cardioversion (DCC) at the completion of initial 6 hour IV bolus or within 24 hours of new onset of atrial fibrillation. Patient will be placed on by mouth amiodarone 400mg three times daily for seven days, then 400mg twice daily for seven days, then 400mg once daily for seven days, then 200mg daily until stop date which will be by provider discretion after discharge from ICU. If the patient does not convert to a normal sinus rhythm with routine DCC then they will remain in the rhythm-control strategy to receive amiodarone as directed. Amiodarone may be extended at discretion of provider for 30 days with discontinuation if adverse effects. If no contraindications, anticoagulation will be recommended prior to DCC with enoxaparin 1mg/kg every 12 hours.
Drug: Amiodarone in Parenteral Dosage Form
Amiodarone IV
Other Name: Cordarone

Drug: Amiodarone Pill
Amiodarone tablet
Other Name: Cordarone

Procedure: Direct Current Cardioversion (DCC)
Convert arrhythmia back to sinus rhythm

Active Comparator: Rate-control strategy
At treating physician's discretion, one of the following, or a combination of the following, will be administered to the patient: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin. The target heart rate is less than 120 beats per minute (bpm) or maintained hemodynamics. Patients in the rate-control arm who are hypotensive after new onset atrial fibrillation can undergo DCC at the provider's discretion and crossover into the rhythm-control arm.
Drug: Rate-control therapy
one or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin

Primary Outcome Measures :
  1. ICU Length of Stay (LOS) [ Time Frame: 28 days ]
    Number of days patient was in the ICU

  2. Ventilation-free days [ Time Frame: 28 days ]
    Days alive and free from mechanical ventilation

  3. Vasopressor days [ Time Frame: 28 days ]
    If vasopressors are administered, number of days patient received vasopressors in the ICU

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • No history of atrial fibrillation
  • Meet Sepsis-3 criteria
  • New onset atrial fibrillation in the ICU
  • Atrial fibrillation treatment warranted
  • Anticoagulation therapy not contraindicated
  • On a ventilator
  • Patient or family member willing to provide informed consent to participate in study

Exclusion Criteria:

  • Post-cardiac or thoracic surgery
  • Hemodynamically unstable
  • Unable to tolerate anticoagulation
  • Physician provider does not agree for patient to participate in study
  • Patient or family member unwilling or unable to provide informed consent
  • Expected death within 24 hours
  • Non-English speakers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04092621

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Contact: Hollis R O'Neal, MD 2253812755

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United States, Louisiana
Our Lady of the Lake Regional Medical Center Not yet recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Hollis R O'Neal, MD    225-381-2755   
Sub-Investigator: Kenneth C Civello, MD         
Sub-Investigator: Omid Baniahmad, MD         
Sponsors and Collaborators
Our Lady of the Lake Regional Medical Center
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Principal Investigator: Hollis R O'Neal, MD Louisiana State University Health Sciences Center

Publications of Results:
Other Publications:

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Responsible Party: Hollis O Neal, Medical Director of Research, Our Lady of the Lake Regional Medical Center Identifier: NCT04092621     History of Changes
Other Study ID Numbers: 19-106
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hollis O Neal, Our Lady of the Lake Regional Medical Center:
new onsent atrial fibrillation
critical care
direct current cardioversion
atrial fibrillation treatment
Additional relevant MeSH terms:
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Respiratory Insufficiency
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Calcium Channel Blockers
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs