Rapid Atrial Fibrillation Treatment Strategy

Sepsis Clinical Trial

— RAFTS  

Official title:

Rapid Atrial Fibrillation Treatment Strategy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04092621
• Other study ID #: 19-106
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 16, 2019
• Est. completion date: September 15, 2020

Study information

• Verified date: September 2019
• Source: Our Lady of the Lake Regional Medical Center
• Contact: Hollis R O'Neal, MD
• Phone: 2253812755
• Email: honeal[@]lsuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• New Onset Atrial Fibrillation
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis

Intervention

Drug:
• Amiodarone in Parenteral Dosage Form
Amiodarone IV
• Amiodarone Pill
Amiodarone tablet

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

Drug:
• Rate-control therapy
one or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin

Locations

Country	Name	City	State
United States	Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Our Lady of the Lake Regional Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Mayr A, Ritsch N, Knotzer H, Dünser 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. — View Citation

Meierhenrich R, Steinhilber E, Eggermann C, Weiss M, Voglic S, Bögelein 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. — View Citation

Sibley S, Muscedere J. New-onset atrial fibrillation in critically ill patients. Can Respir J. 2015 May-Jun;22(3):179-82. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

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