Rapid Atrial Fibrillation Treatment Strategy

NCT04092621 | Unknown Phase 4 FDA Drug

• 1 other identifier: 19-106
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

New Onset Atrial Fibrillation; Sepsis; Respiratory Failure

Keywords

new onsent atrial fibrillation; sepsis; critical care; direct current cardioversion; atrial fibrillation treatment

Outcome Measures

Primary Outcomes (3)

• ICU Length of Stay (LOS)

  Number of days patient was in the ICU

  28 days

• Ventilation-free days

  Days alive and free from mechanical ventilation

  28 days

• Vasopressor days

  If vasopressors are administered, number of days patient received vasopressors in the ICU

  28 days

Study Arms (2)

Rhythm-control strategy

EXPERIMENTAL

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; Drug: Amiodarone Pill; Procedure: Direct Current Cardioversion (DCC)

Rate-control strategy

ACTIVE COMPARATOR

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

Interventions

Amiodarone in Parenteral Dosage Form DRUG

Amiodarone IV

Also known as: Cordarone

Rhythm-control strategy

Amiodarone Pill DRUG

Amiodarone tablet

Also known as: Cordarone

Rhythm-control strategy

Direct Current Cardioversion (DCC) PROCEDURE

Convert arrhythmia back to sinus rhythm

Rhythm-control strategy

Rate-control therapy DRUG

one or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin

Rate-control strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Our Lady of the Lake Hospital: lead

Study Sites (1)

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (12)

• Meierhenrich R, Steinhilber E, Eggermann C, Weiss M, Voglic S, Bogelein D, Gauss A, Georgieff M, Stahl W. Incidence and prognostic impact of new-onset atrial fibrillation in patients with septic shock: a prospective observational study. Crit Care. 2010;14(3):R108. doi: 10.1186/cc9057. Epub 2010 Jun 10.

  PMID: 20537138 BACKGROUND

• Yoshida T, Fujii T, Uchino S, Takinami M. Epidemiology, prevention, and treatment of new-onset atrial fibrillation in critically ill: a systematic review. J Intensive Care. 2015 Apr 23;3(1):19. doi: 10.1186/s40560-015-0085-4. eCollection 2015.

  PMID: 25914828 BACKGROUND

• Caldeira D, David C, Sampaio C. Rate versus rhythm control in atrial fibrillation and clinical outcomes: updated systematic review and meta-analysis of randomized controlled trials. Arch Cardiovasc Dis. 2012 Apr;105(4):226-38. doi: 10.1016/j.acvd.2011.11.005. Epub 2012 Jan 21.

  PMID: 22633297 BACKGROUND

• Chean CS, McAuley D, Gordon A, Welters ID. Current practice in the management of new-onset atrial fibrillation in critically ill patients: a UK-wide survey. PeerJ. 2017 Sep 8;5:e3716. doi: 10.7717/peerj.3716. eCollection 2017.

  PMID: 28929012 BACKGROUND

• Sibley S, Muscedere J. New-onset atrial fibrillation in critically ill patients. Can Respir J. 2015 May-Jun;22(3):179-82. doi: 10.1155/2015/394961.

  PMID: 26057373 BACKGROUND

• Walkey AJ, Hogarth DK, Lip GYH. Optimizing atrial fibrillation management: from ICU and beyond. Chest. 2015 Oct;148(4):859-864. doi: 10.1378/chest.15-0358.

  PMID: 25951122 BACKGROUND

• Kanji S, Williamson DR, Yaghchi BM, Albert M, McIntyre L; Canadian Critical Care Trials Group. Epidemiology and management of atrial fibrillation in medical and noncardiac surgical adult intensive care unit patients. J Crit Care. 2012 Jun;27(3):326.e1-8. doi: 10.1016/j.jcrc.2011.10.011. Epub 2012 Jan 4.

  PMID: 22226423 BACKGROUND

• Mayr A, Ritsch N, Knotzer H, Dunser M, Schobersberger W, Ulmer H, Mutz N, Hasibeder W. Effectiveness of direct-current cardioversion for treatment of supraventricular tachyarrhythmias, in particular atrial fibrillation, in surgical intensive care patients. Crit Care Med. 2003 Feb;31(2):401-5. doi: 10.1097/01.CCM.0000048627.39686.79.

  PMID: 12576943 BACKGROUND

• Walkey AJ, Greiner MA, Heckbert SR, Jensen PN, Piccini JP, Sinner MF, Curtis LH, Benjamin EJ. Atrial fibrillation among Medicare beneficiaries hospitalized with sepsis: incidence and risk factors. Am Heart J. 2013 Jun;165(6):949-955.e3. doi: 10.1016/j.ahj.2013.03.020. Epub 2013 Apr 25.

  PMID: 23708166 BACKGROUND

• Arrigo M, Jaeger N, Seifert B, Spahn DR, Bettex D, Rudiger A. Disappointing Success of Electrical Cardioversion for New-Onset Atrial Fibrillation in Cardiosurgical ICU Patients. Crit Care Med. 2015 Nov;43(11):2354-9. doi: 10.1097/CCM.0000000000001257.

  PMID: 26468695 BACKGROUND

• Walkey AJ, Wiener RS, Ghobrial JM, Curtis LH, Benjamin EJ. Incident stroke and mortality associated with new-onset atrial fibrillation in patients hospitalized with severe sepsis. JAMA. 2011 Nov 23;306(20):2248-54. doi: 10.1001/jama.2011.1615. Epub 2011 Nov 13.

  PMID: 22081378 BACKGROUND

• Liu WC, Lin WY, Lin CS, Huang HB, Lin TC, Cheng SM, Yang SP, Lin JC, Lin WS. Prognostic impact of restored sinus rhythm in patients with sepsis and new-onset atrial fibrillation. Crit Care. 2016 Nov 18;20(1):373. doi: 10.1186/s13054-016-1548-2.

  PMID: 27855722 RESULT

MeSH Terms

Conditions

Sepsis; Respiratory Insufficiency

Interventions

Amiodarone; Injections; Electric Countershock

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Electric Stimulation Therapy

Study Officials

• Hollis R O'Neal, MD

  Louisiana State University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hollis R O'Neal, MD

CONTACT

2253812755; honeal@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Research

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 17, 2019
• Study Start: September 16, 2019
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)