Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- plasma level of sodium nitrite at hospital arrival
研究概览
简要总结
The purpose of this study is to determine the optimal dose of sodium nitrate administered during resuscitation to achieve a plasma level of 10 μM by hospital arrival.
Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV dose of sodium nitrite will achieve the optimal (based on preclinical studies) neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100 patients, we will determine whether 25 mg IV administered during resuscitation will achieve plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either decreasing or increasing, will be made if necessary permitting us to determine the optimal nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Intravenous access/intraosseous access
- •Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One paramedics.
- •Age 18 years or older
排除标准
- •Traumatic cause of cardiac arrest
- •Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
- •Drowning as cause of arrest.
结局指标
主要结局
plasma level of sodium nitrite at hospital arrival
时间窗: 15-45 minutes after dose has been given
次要结局
- Rate of re-arrest(15-120 minutes after dose has been given)
- Need for pressor support before hospital arrival(15-120 minutes after dose has been given)
研究者
Francis Kim
Associate Professor, Medicine/Division of Cardiology
University of Washington