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临床试验/NCT01362556
NCT01362556已完成不适用

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

Medical University of Graz6 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

Group receiving sodium chloride 0.9% after arterial blood gas analysis in cardiac arrest.

干预措施: Sodium Chloride (Drug)

Sodium Bicarbonate

Active Comparator

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

发起方
Medical University of Graz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prause Gerhard, MD

Prof Dr

Medical University of Graz

研究点 (6)

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