New Onset Atrial FibrillationPhase 4RAFTSNCT04092621
Rapid Atrial Fibrillation Treatment Strategy
A Phase 4 study testing Amiodarone in Parenteral Dosage Form, Amiodarone Pill and Direct Current Cardioversion (DCC) in people with New Onset Atrial Fibrillation and Sepsis, run by Our Lady of the Lake Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- New Onset Atrial Fibrillation, Sepsis, Respiratory Failure
- What is being tested?
- Amiodarone in Parenteral Dosage Form, Amiodarone Pill and Direct Current Cardioversion (DCC)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 15 Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
Hollis R O'Neal, MD, 225-381-2755, honeal@lsuhsc.edu
Kenneth C Civello, MD
About this study
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.
Read the 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
- Conditions
- New Onset Atrial Fibrillation, Sepsis, Respiratory Failure
- Being tested
- Amiodarone in Parenteral Dosage Form, Amiodarone Pill, Direct Current Cardioversion (DCC), Rate-control therapy
- Keywords
- new onsent atrial fibrillation, sepsis, critical care, direct current cardioversion, atrial fibrillation treatment
- Medical subject headings
- Sepsis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiodarone in Parenteral Dosage FormDrug
Also called Cordarone
Amiodarone IV
Amiodarone PillDrug
Also called Cordarone
Amiodarone tablet
Direct Current Cardioversion (DCC)Procedure or surgery
Convert arrhythmia back to sinus rhythm
Rate-control therapyDrug
one or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Rate-control therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Length of Stay (LOS)
Number of days patient was in the ICU
Measured: 28 days
Ventilation-free days
Days alive and free from mechanical ventilation
Measured: 28 days
Vasopressor days
If vasopressors are administered, number of days patient received vasopressors in the ICU
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start16 Sep 2019 (estimated)
- Primary completion15 Sep 2020 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for New Onset Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Our Lady of the Lake Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollis O Neal, Our Lady of the Lake Hospital
- Investigators
- Hollis R O'Neal, MD, Principal investigator, Louisiana State University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092621
- Sponsor's protocol ID
- 19-106
- Acronym
- RAFTS
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20537138Yoshida 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.
PubMed 25914828Caldeira 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.
PubMed 22633297Chean 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.
PubMed 28929012Sibley 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.
PubMed 26057373Walkey 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.
PubMed 25951122Kanji 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.
PubMed 22226423Mayr 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.
PubMed 12576943Walkey 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.
PubMed 23708166Arrigo 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.
PubMed 26468695Walkey 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.
PubMed 22081378Liu 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.
PubMed 27855722
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Atrial Fibrillation Treatment Strategy
- ClinicalTrials.gov ID
- NCT04092621
- Acronym / sponsor ID
- RAFTS / 19-106
- Conditions
- New Onset Atrial Fibrillation, Sepsis, Respiratory Failure
- Keywords
- new onsent atrial fibrillation, sepsis, critical care, direct current cardioversion, atrial fibrillation treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Our Lady of the Lake HospitalUniversity, hospital or other
- Study start
- 16 Sep 2019 (estimated)
- Primary completion
- 15 Sep 2020 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythm-control strategy | Experimental | Drug: Amiodarone in Parenteral Dosage Form, Drug: Amiodarone Pill, Procedure: Direct Current Cardioversion (DCC)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. |
| Rate-control strategy | Active comparator | Drug: Rate-control therapyAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- No history of atrial fibrillation
- Meet Sepsis-3 criteria
- New onset atrial fibrillation in the ICU
- Atrial fibrillation treatment warranted
- Anticoagulation therapy not contraindicated
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amiodarone in Parenteral Dosage FormAlso: CordaroneAmiodarone IV | Drug | Rhythm-control strategy |
| Amiodarone PillAlso: CordaroneAmiodarone tablet | Drug | Rhythm-control strategy |
| Direct Current Cardioversion (DCC)Convert arrhythmia back to sinus rhythm | Procedure or surgery | Rhythm-control strategy |
| Rate-control therapyone or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin | Drug | Rate-control strategy |
Primary outcome
ICU Length of Stay (LOS)
Time frame: 28 days
Number of days patient was in the ICU
Ventilation-free days
Time frame: 28 days
Days alive and free from mechanical ventilation
Vasopressor days
Time frame: 28 days
If vasopressors are administered, number of days patient received vasopressors in the ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Background: PubMed 20537138Meierhenrich 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.
- Background: PubMed 25914828Yoshida 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.
- Background: PubMed 22633297Caldeira 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.
- Background: PubMed 28929012Chean 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.
- Background: PubMed 26057373Sibley 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.
- Background: PubMed 25951122Walkey 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.
- Background: PubMed 22226423Kanji 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.
- Background: PubMed 12576943Mayr 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.
- Background: PubMed 23708166Walkey 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.
- Background: PubMed 26468695Arrigo 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.
- Background: PubMed 22081378Walkey 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.
- Results publication: PubMed 27855722Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hollis R O'Neal, MD principal investigator
Louisiana State University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amiodarone in Parenteral Dosage Form, Amiodarone Pill and Direct Current Cardioversion (DCC) in people with New Onset Atrial Fibrillation and Sepsis, run by Our Lady of the Lake Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hollis R O'Neal, MD (2253812755, honeal@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Length of Stay (LOS) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04092621, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.