Controlling Hyperadrenergic Activity in Neurologic Injury
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Controlling heart rate in traumatic brain injured patients
研究概览
简要总结
Traumatic brain injury (TBI) is frequently associated with a hyperadrenergic state accompanied by elevated levels of plasma catecholamines. In its more severe presentation, the hyperadrenergic state presents as dysautonomia, which is characterized by paroxysmal alteration in vital signs, including tachycardia. The investigators hypothesize that intravenous (IV) esmolol is as effective at controlling heart rate in hyperadrenergic states as oral propranolol, which is the standard of care. Our primary endpoint is efficacy of IV esmolol vs a PRN regimen of intermittent B-blockade in controlling heart rate below a pre-specified level (< 100 bpm) after Traumatic Brain Injury (TBI) or hemorrhagic neurologic injury. Heart rates will be recorded continuously as well as hourly.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TBI (Moderate/Severe TBI (GCS 12 or Head AIS>1) or hemorrhagic neurologic injury
- •Hyperadrenergic Activity: At least one paroxysmal episode (lasting at least 15 minutes) of Heart Rate 110 beats per minute during two or more consecutive days plus at least two more of the following that may not be better explained by another disease process (ex: sepsis):
- •Temperature of 38.5C Respiratory Rate 20 breaths per minute Agitation Diaphoresis Dystonia Stimulus responsive ("triggering of paroxysm")
- •Informed Consent obtained
排除标准
- •Patients that do not meet criteria for dysautonomia (as stated above)
- •Age <18 years
- •Pregnancy
- •Hypotension - requiring pressor therapy to maintain baseline adequate CPP or mean arterial pressure
- •Cardiac arrhythmia - sinus bradycardia (HR <60), 2nd or 3rd degree AV block
- •Hemodynamic contraindications to intravenous beta-blockade such as a documented history of congestive heart failure (CHF), dependency on cardiac inotropes or documented bronchospastic disease
- •Any patient on chronic beta blockade as an outpatient.
- •Life expectancy < 48 hours or patients with "do not resuscitate orders"
- •Ongoing seizure activity
- •Informed consent not obtained
研究组 & 干预措施
Subjects Receiving Esmolol
The Esmolol arm is defined as a 48-hour intravenous infusion of esmolol (Brevibloc 20mg/ml), which will be started on enrollment.
干预措施: Esmolol (Drug)
Subjects receiving Propranolol
The comparison arm will be comprised of oral propranolol, starting with 20mg PO every 6 hours prn (as needed) to reduce heart rate into target range. If 20mg is ineffective, the dose will be doubled at each dosing interval until an adequate dose is found, not to exceed 120mg four times daily. (ex: 20mg, 40mg, 80mg, 120mg)
干预措施: Propranolol (Drug)
结局指标
主要结局
Controlling heart rate in traumatic brain injured patients
时间窗: 72 hrs
Once the patient is randomized and start getting the study medication, we monitor heart rate and other vital signs for 72hrs
次要结局
未报告次要终点
研究者
Wendy Ziai
Associate Professor
Johns Hopkins University