Randomized Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,502
- 试验地点
- 1
- 主要终点
- Number of Participants Who Survived to Hospital Admission
研究概览
简要总结
In this clinical study, a total of 1500 patients with out-of-hospital cardiac arrest in Seattle/King County will be enrolled. This will be a randomized clinical trial and patients will receive either two different doses of IV sodium nitrite (45 mg or 60 mg) or placebo during resuscitation in the field by paramedics. The primary outcome will be proportion of patients surviving to hospital admission.
详细描述
The hemodynamic effects of the optimal dose of IV nitrite administered in patients with cardiac arrest are unknown. A significant negative hemodynamic effect from nitrite would decrease the proportion of patients admitted to the hospital, increase rate of re-arrest, or increase the need for vasopressor support in the field. In Seattle/King County, typically 40% of out-of-hospital cardiac arrest patients attended to by paramedics have Return of spontaneous circulation (ROSC) and are admitted to the hospital. In this study, 1500 patients with out-of-hospital cardiac arrest who are undergoing resuscitation by paramedics will be randomized to receive placebo (n=500) or 45 mg IV (n=500) or 60 mg dose (n=500) of sodium nitrite. The study will have 80% power to detect an absolute increase in hospital admission rate of 8% (1-sided .05 level test for each of the two comparisons (45 mg vs placebo and 60 mg vs placebo, no adjustment for multiple comparisons), with a hospital admission rate of 40% in the placebo group and with one interim analysis and stopping only for potential futility and/or harm). The investigators will examine the proportion of patients who survive to discharge as a secondary measure of efficacy.
Patients will be eligible for this study if:
- Intravenous access (IV)/intraosseous access(IO)
- Cardiac arrest, either Ventricular Fibrillation (VF) or non-VF patients receiving Advanced Cardiac Life Support (ACLS) by Seattle/King County paramedics.
- Age 18 years or older
- Comatose
Exclusion Criteria
- Traumatic cause of cardiac arrest
- Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
- Known DNAR
- Drowning as cause of arrest.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Cardiac arrest, either VF or non-VF, patients receiving ACLS by paramedics
- •IV or IO access
排除标准
- •traumatic cause of cardiac arrest
- •prisoner, pregnancy
- •known DNAR
研究组 & 干预措施
Placebo
2 ml of normal saline (n=500)
干预措施: Placebo (Drug)
sodium nitrite
45 mg IV of sodium nitrite (n=500) or 60 mg IV sodium nitrite (n=500) given during active resuscitation from out of hospital cardiac arrest.
干预措施: sodium nitrite 45 mg (Drug)
sodium nitrite
45 mg IV of sodium nitrite (n=500) or 60 mg IV sodium nitrite (n=500) given during active resuscitation from out of hospital cardiac arrest.
干预措施: sodium nitrite 60 mg (Drug)
结局指标
主要结局
Number of Participants Who Survived to Hospital Admission
时间窗: within 24 hours after out of hospital cardiac arrest
Patient has sustained pulse at arrival to the emergency department
次要结局
- Survival to 24 Hours(within first 24 h after hospital admission)
- Number of Days in ICU(Within first 3 months of hospital admission)
- Survival to Discharge(within 3-6 months after cardiac arrest)
- Re-arrest(before hospital arrival)
- Survival to 48 Hours After Admission to Hospital(within first 48 hours after admission to hospital)
- Survival to 72 Hours After Admission to Hospital(within first 72 hours after admission to hospital)
研究者
Francis Kim
Professor, Medicine/Division of Cardiology
University of Washington