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临床试验/NCT06131892
NCT06131892已完成不适用

Defibrillation in Accidental Hypothermia: a Retrospective Study of the International Hypothermia Registry

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
the number of patients with a core temperature equal or less than 30°C who had a successful defibrillation, defined as ROSC for at least 30 seconds

研究概览

简要总结

Hypothermia (core temperature ≤35°C) is a frequent and life-threatening complication after mountain accidents, near-drowning, and intoxications, and can provoke arrhythmia, reduced cardiac contractility, and cardiac arrest. The hypothermic heart may be insensitive to defibrillation with a core temperature <30°C. Also, below <30°C after successful defibrillation, a perfusing rhythm often degenerates to ventricular fibrillation (VF) again. Repeated defibrillation can induce myocardial injury. Thus, the guidelines of the European Resuscitation Council (ERC) suggest delaying further defibrillation attempts until the core temperature is >30°C if VF persists after 3 shocks. Epinephrine should be withheld if core temperature is <30°C. Advanced Life Support (ALS) guidelines of the American Heart Association (AHA) state that it may be reasonable to perform further defibrillation attempts according to the standard algorithm and to consider administration of a vasopressor during cardiac arrest (Table 1). This discrepancy between ERC and AHA guidelines can be explained by the different interpretations of mainly animal data, which show that vasopressors increase the chances of successful defibrillation <30°C, defined as return of spontaneous circulation (ROSC) for at least 30 seconds. The guidelines of the Wilderness and Environmental Medicine Society (WMS) state that a single shock at a maximum power can be given for patients with a temperature <30°C.

The aim of this study is to evaluate clinical course of hypothermic patients(<30°C) undergoing defibrillation. The primary aim is to evaluate the success ratio of defibrillation, defined as ROSC for at least 30 seconds. Secondary aims are the recurrence rate of ventricular fibrillation, the number of defibrillation attempts per patient, the presence of cardiac dysfunction after defibrillation and the cerebral performance category (CPC) score at the end of hospitalization.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients of the International Hypothermia Registry with a defibrillation while having a body core temperature equal or less than 30°C

排除标准

  • patients of the International Hypothermia Registry with a body core temperature >30°C
  • patients who refused to participate

结局指标

主要结局

the number of patients with a core temperature equal or less than 30°C who had a successful defibrillation, defined as ROSC for at least 30 seconds

时间窗: through study completion, an average of 3 months

次要结局

  • the number of patients with a return to ventricular fibrillation after successful defibrillation(through study completion, an average of 3 months)
  • the rate of defibrillation attempts per patient(through study completion, an average of 3 months)
  • the number of patients with the presence of cardiac dysfunction after defibrillation(through study completion, an average of 3 months)
  • cerebral performance category (CPC) score of every patient at the end of hospitalization(through study completion, an average of 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Evelien Cools

Medical Doctor, Principal Investigator

University Hospital, Geneva

研究点 (1)

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