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临床试验/NCT04092621
NCT04092621Unknown4 期

Rapid Atrial Fibrillation Treatment Strategy

Our Lady of the Lake Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年9月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
40
试验地点
1
主要终点
Vasopressor days

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Amiodarone in Parenteral Dosage Form (Drug)

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.

干预措施: Amiodarone Pill (Drug)

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.

干预措施: Direct Current Cardioversion (DCC) (Procedure)

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.

干预措施: Rate-control therapy (Drug)

结局指标

主要结局

Vasopressor days

时间窗: 28 days

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

ICU Length of Stay (LOS)

时间窗: 28 days

Number of days patient was in the ICU

Ventilation-free days

时间窗: 28 days

Days alive and free from mechanical ventilation

次要结局

未报告次要终点

研究者

发起方
Our Lady of the Lake Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hollis O Neal

Medical Director of Research

Our Lady of the Lake Hospital

研究点 (1)

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