跳至主要内容
临床试验/NCT04997980
NCT04997980已完成不适用

aMsa and amiOdarone Study in cArdiaC Arrest

Fondazione IRCCS Policlinico San Matteo di Pavia4 个研究点 分布在 3 个国家目标入组 629 人开始时间: 2015年1月1日最近更新:
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
629
试验地点
4
主要终点
AMSA values

研究概览

简要总结

Investigators' aim is to assess whether the administration of amiodarone during resuscitation could cause a reduction of the values of the amplitude spectral area (AMSA).

Amiodarone is recommended for the treatment of cardiac arrest due to ventricular tachycardia/ventricular fibrillation (VT/VF) ( with a low level of recommendation cause of conflicting results. AMSA is a parameter expressing the amplitude of VF and it has been shown to predict defibrillation success and the return of spontaneous circulation (ROSC). No data are available so far about the impact of amiodarone administration on AMSA values.

详细描述

The primary study endpoint of the present study is to determine whether patients who received amiodarone during advanced resuscitation had lower values of AMSA as compared to those who did not receive amiodarone.

Secondary endpoints

The secondary endpoints of this study are:

  1. To assess, after correction for confounders, the rate of successful defibrillation, the rate of ROSC and the rate of short-term survival (survived event or survival to hospital discharge according to the available data) both in the amiodarone and non-amiodarone group.
  2. To assess the role of AMSA for shock success and ROSC prediction in amiodarone group and in non-amiodarone group.

Type of study. This is a multicentre study based on a retrospective analysis of prospectically collected data.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
1 Year 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with out-of-hospital cardiac arrest
  • shockable presenting rhythm
  • resuscitation attempted
  • advanced resuscitation attempted
  • technical: - VF cardiac arrest (and not VT)

排除标准

  • non-shockable presenting rhythm
  • resuscitation not attempted
  • AMSA not evaluable

研究组 & 干预措施

Amiodarone group

Patients who did receive amiodarone during the attempt of resuscitation

干预措施: Amiodarone Injection (Drug)

结局指标

主要结局

AMSA values

时间窗: through study completion, an average of 1 year

to determine whether AMSA values in the Amiodarone group are lower than in the NO Amiodarone gorup

次要结局

  • Successful defibrilaltion(through study completion, an average of 1 year)
  • Survived event(through study completion, an average of 1 year)
  • ROSC(through study completion, an average of 1 year)
  • Survival to hospital discharge(through study completion, an average of 1 year)
  • Prediction(through study completion, an average of 1 year)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Savastano

principal investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (4)

Loading locations...

相似试验