Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2019-09-16
2020-09-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery
NCT02750319
Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response
NCT06262932
Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.
NCT00050076
Landiolol for Rate Control in Decompensated Heart Failure Due to Atrial Fibrillation
NCT04694092
Comparison of Diltiazem and Metoprolol in the Management of Acute Atrial Fibrillation or Atrial Flutter
NCT01914926
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Amiodarone in Parenteral Dosage Form
Amiodarone IV
Amiodarone Pill
Amiodarone tablet
Direct Current Cardioversion (DCC)
Convert arrhythmia back to sinus rhythm
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.
Rate-control therapy
one or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amiodarone in Parenteral Dosage Form
Amiodarone IV
Amiodarone Pill
Amiodarone tablet
Direct Current Cardioversion (DCC)
Convert arrhythmia back to sinus rhythm
Rate-control therapy
one or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Our Lady of the Lake Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hollis O Neal
Medical Director of Research
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hollis R O'Neal, MD
Role: PRINCIPAL_INVESTIGATOR
Louisiana State University Health Sciences Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
19-106
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.