Beta-1 Adrenergic Inhibition to Reduce Cardiac Injury and Inflammation After Subarachnoid Hemorrhage (BADCATS)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Delta neutrophil activity
研究概览
简要总结
To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH).
详细描述
To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH) on the brain and cardiac tissue damage and inflammation, we will conduct a pilot randomized controlled trial comparing (1) sympathetic nervous system (SNS) activation, (2) cardiac rhythm abnormalities, (3) biomarkers of brain and cardiac tissue damage, and (4) and neutrophil activity in patients receiving metoprolol (n=10) or placebo (n=10) for the first 72-hours after SAH.
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
- 否
入选标准
- •>18 years of age
- •Neuro-imaging confirmed non-traumatic subarachnoid hemorrhage
排除标准
- •Traumatic cause of subarachnoid hemorrhage (e.g. fall, motor vehicle accident, other blunt trauma) as this is a different mechanism of hemorrhage.
- •Other forms of traumatic or non-traumatic intracranial bleed including intracerebral hemorrhage (ICH), subdural hemorrhage, epidural hemorrhage
- •Pregnancy (as the study medication, metoprolol, has FDA Pregnancy Category C rating)
- •Unstable vital signs not amenable to beta-1 adrenergic receptor inhibitor (B1ARi) administration including:
- •Systolic blood pressure < 80 mmHg not stabilized on vasopressor medications
- •Heart rate < 50 bpm associated with hypotension
- •Patients requiring vasopressor agents due to hypotension (SBP <80 mmHg)
- •Other vital sign exclusion at the discretion of the treatment team
- •Previous history of severe heart failure (Stage C or D Heart Failure and/or NYHA Class III or IV)
- •Patient or legally authorized representative unwilling to provide informed consent
研究组 & 干预措施
Metoprolol (Beta-adrenergic blockade)
Patients will receive metoprolol during the first 72-hours of hospitalization after non-traumatic SAH.
干预措施: Metoprolol (Drug)
Placebo
Patients will receive placebo during the first 72-hours of hospitalization after non-traumatic SAH.
干预措施: Placebo (Drug)
结局指标
主要结局
Delta neutrophil activity
时间窗: 7 days
Delta neutrophil activity between intervention and control groups.
Delta QTc length
时间窗: 7 days
Change (Delta) QTc length between intervention and control groups.
次要结局
- Adverse events(7-days)
- Number of patients with evidence of cardiac injury(7-days)
- Need for Vasopressors(7-days)
- Sympathetic Nervous System (SNS) Activity(7-days)
- ICU Length of Stay (LOS)(Up to 15-weeks)
- In-hospital mortality(Up to 15-weeks)
- Neutrophil Activity(7 days)
- Evidence of Clinical Vasospasm(Up to 15-weeks)
- Hospital Length of Stay (LOS)(Up to 15-weeks)
研究者
Madeleine Puissant
Assistant Professor of Emergency Medicine
MaineHealth