NCT02303548已完成2 期
Pilot Study of Bicarbonate Injection for Improving Outcome in Patients With Out-of-hospital Cardiac Arrest, Double-blind Randomized Control Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Return of Spontaneous Circulation (ROSC)
研究概览
简要总结
A pilot study to evaluate the effect of sodium bicarbonate administration on cardiopulmonary resuscitation results and outcomes in cardiac arrest patient with severe metabolic acidosis.
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
- Triple (Participant, Care Provider, Investigator)
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
- •adult cardiac arrest patient with arterial pH <7.1 or bicarbonate <10mmEq/L checked at 10 minutes of cardiopulmonary resuscitation
排除标准
- •age <18 trauma patient Do Not Resuscitate state
研究组 & 干预措施
1 (Sodium bicarbonate)
Experimental
Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min
干预措施: Sodium bicarbonate (Drug)
2 (Normal saline)
Placebo Comparator
Normal saline 50cc intravenous injection over 2 min
干预措施: Normal saline (Drug)
结局指标
主要结局
Return of Spontaneous Circulation (ROSC)
时间窗: checked during CPR, duration of ROSC >20 min
Percentage of Participants with Return of Spontaneous Circulation (ROSC)
次要结局
未报告次要终点
研究者
Won Young Kim
Associate proffesor
Asan Medical Center
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