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临床试验/NCT00312273
NCT00312273已完成2 期

Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial

Vancouver General Hospital2 个研究点 分布在 1 个国家目标入组 966 人开始时间: 2001年1月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
966
试验地点
2
主要终点
The return of spontaneous circulation (ROSC), defined as the development of a palpable pulse of any duration.

研究概览

简要总结

The purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest.

详细描述

Out-of-hospital cardiac arrest treated by emergency medical services has an estimated incidence of 54.99 per 100,000 person years, which translates to some 155,000 episodes annually in the United States. Bradyasystole is the first recorded rhythm in up to 52 percent of cardiac arrests, and many additional patients with an initial cardiac arrest rhythm of ventricular fibrillation deteriorate to bradyasystole after defibrillation efforts. Survival to hospital discharge occurs in less than 3 percent of patients presenting with bradyasystole; however, due to its frequency, this rhythm accounts for over 17 percent of all cardiac arrest survivors. As a result, even a small improvement in survival from bradyasystolic cardiac arrest would result in thousands of lives saved annually.

Adenosine is an endogenous purine nucleoside that depresses the sinoatrial node, blocks atrioventricular conduction, inhibits the pacemaker activity of the His-Purkinje system and attenuates the effects of catecholamines. Since adenosine is produced and released by myocardial cells during ischemia and hypoxia, it may be a reversible factor in the etiology or perpetuation of bradyasystole. Aminophylline is a competitive antagonist of adenosine. The use of aminophylline for bradycardia and heart block has been described, and a number of anecdotal reports and small studies have been published on the use of aminophylline in cardiac arrest. We undertook this study to evaluate the effect of aminophylline during cardiopulmonary resuscitation (CPR) of patients with out-of-hospital bradyasystolic cardiac arrest unresponsive to initial therapy.

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
Double

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cardiac arrest
  • Bradyasystole either as the presenting rhythm or as a rhythm developing during the course of the resuscitation
  • Endotracheally intubated and ventilated with 100% oxygen
  • Intravenous (IV) access established
  • Bradyasystolic without palpable pulses after 1 mg of epinephrine and 3 mg of atropine.

排除标准

  • A do-not-resuscitate directive
  • Pregnancy
  • Evidence of hemorrhage, trauma or hypothermia as a cause of the cardiac arrest
  • Renal dialysis
  • Theophylline hypersensitivity
  • Patients taking an oral theophylline product
  • Resuscitations directed by a paramedic student under practicum supervision

结局指标

主要结局

The return of spontaneous circulation (ROSC), defined as the development of a palpable pulse of any duration.

次要结局

  • Maximum duration of ROSC (the duration of the longest episode of sustained pulse return)
  • ROSC duration by survival analysis
  • Survival to hospital admission
  • Survival to hospital discharge
  • Length of hospital stay
  • Non-sinus tachyarrhythmias in the first 24 hours after study drug administration
  • Seizures in the first 24 hours after study drug administration
  • Neurologic outcome
  • Proportion of subjects receiving one versus two doses of study drug
  • Proportion of subjects achieving ROSC with initial-rhythm bradyasystole versus bradyasystole which developed after paramedic arrival.

研究者

申办方类型
Other

研究点 (2)

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