Blood Gas Analysis and Buffering In Cardiac Arrest - A Multicenter, Prospective, Randomised, Double Blind Prehospital Trial to Evaluate the Impact of Early Blood-gas-analysis Targeted Buffer Therapy on ROSC After OOHCA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 6
- 主要终点
- Rate of return of spontaneous circulation (ROSC)
研究概览
简要总结
The debate over the administration of sodium bicarbonate in cardiac arrest has been going on for several decades, swinging like a pendulum from "first-line drug" to "not indicated" to the recent guidelines advocating "a small bolus under special conditions (metabolic acidosis, intoxication, long-term resuscitation)". A targeted, blood-gas controlled application under optimised ventilation conditions has not yet been evaluated prehospitally. Our preliminary studies have shown that an arterial puncture/line as well as measurement of blood gases is feasible in preclinical conditions. This multicentre trial including 5 centres and 10 physician-staffed emergency systems is designed to compare, in a prospective randomised controlled study, the effect of a calculated dosage of sodium bicarbonate based on the patient´s base deficit and weight, on ROSC (= return of spontaneous circulation) and on the secondary survival of cardiac arrest patients. The null hypothesis is that there is no or negative impact on survival.
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
- •prehospitally started cardiopulmonary resuscitation (CPR)
- •advanced cardiac life support provided
- •age >18 years
- •arterial pH < 7,2
- •arterial BE < -12
- •arterial pCO2 15-75 mmHg
- •arterial pO2 >35 mmHg
排除标准
- •women of childbearing age
- •traumatic cardiac arrest
研究组 & 干预措施
Sodium Chloride
Group receiving sodium chloride 0.9% after arterial blood gas analysis in cardiac arrest.
干预措施: Sodium Chloride (Drug)
Sodium Bicarbonate
Group receiving targeted sodium bicarbonate 8% therapy after arterial blood gas analysis in cardiac arrest.
干预措施: Sodium bicarbonate (Drug)
结局指标
主要结局
Rate of return of spontaneous circulation (ROSC)
时间窗: Within five hours from start of resuscitation.
次要结局
- Survival to discharge after cardiac arrest(participants will be followed for the duration of hospital stay, an expected average of 5 weeks)
- Survival after one year of hospital discharge(One year after event)
研究者
Prause Gerhard, MD
Prof Dr
Medical University of Graz
