Rapid Atrial Fibrillation Treatment Strategy (RAFTS)

September 13, 2019 updated by: Hollis O Neal, Our Lady of the Lake Regional Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Regional Medical Center
        • Contact:
        • Sub-Investigator:
          • Kenneth C Civello, MD
        • Sub-Investigator:
          • Omid Baniahmad, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Cordarone
Drug: Amiodarone Pill
Amiodarone tablet
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Length of Stay (LOS)
Time Frame: 28 days
Number of days patient was in the ICU
28 days
Ventilation-free days
Time Frame: 28 days
Days alive and free from mechanical ventilation
28 days
Vasopressor days
Time Frame: 28 days
If vasopressors are administered, number of days patient received vasopressors in the ICU
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Our Lady of the Lake Regional Medical Center

Investigators

  • Principal Investigator: Hollis R O'Neal, MD, Louisiana State University Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 16, 2019

Primary Completion (ANTICIPATED)

September 15, 2020

Study Completion (ANTICIPATED)

September 15, 2020

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

September 13, 2019

First Posted (ACTUAL)

September 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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