International Hypothermia Registry: a Registry With Worldwide Cases of Accidental Hypothermia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 16
- 主要终点
- The Registry is a questionnaire, containing 252 variables divided into a demographical, prehospital, hospital and outcome section. The collected measurement data will be registered on REDCap.
研究概览
简要总结
Transient mild hypothermia (core body temperature 35-32°C) is common and usually without consequences for the brain or other organs. However, prolonged severe accidental hypothermia (core body temperature below 28°C) due to accidents is rare, and usually fatal in more than 50% of cases. Little is known on its physiopathology, on prognostic factors for rewarming decision or ideal rewarming techniques for better survival. Furthermore, complications after successful rewarming are extremely frequent and very often severe or fatal.
Accidental hypothermia is a frequent problem during the winter months and can be caused by snow sport accidents, near drowning and urban cold exposure. The International Hypothermia Registry's principle goal is to increase knowledge on accidental hypothermia by creating the largest database on accidental hypothermia which will comprise enough patient data to give a statistical power since the causes of accidental hypothermia and its treatment varies greatly.
The International Hypothermia Registry (IHR) will enable improvement of pre- and in-hospital treatment and rewarming methods, study survival predictors and prevention of post-rewarming complications. By this way, the IHR will permit the establishment of evidence-based diagnosis and treatment guidelines.
详细描述
The aim of the International Hypothermia Registry is to improve rescue, treatment and outcome of accidental hypothermia victims.
The principal objectives of the International Hypothermia Registry are:
- Improving the outcome of accidental hypothermic patients (survival and normal neurologic function);
- This outcome is dependent on the presenting status of the patient (temperature, trauma, cardiac arrest, etc.);
- The hospital treatment and rewarming method will also influence the outcome, invasive vs. non-invasive rewarming and rewarming rate.
- Quality control, assessment of hypothermia cases
This IHR is mainly prospective but retrospective entries are welcome.
There is no data limit on retrospective cases: cases of any year can be entered.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Accidental hypothermia with body core temperatures equal or less than 35°C/95°F;
- •Any cause leading to accidental hypothermia (e.g. mountain, water, urban);
- •Any age, gender, or comorbidities;
- •Any pre-hospital and hospital treatment and rewarming;
- •Any outcome.
排除标准
- •Patient opposition to be part of a study;
- •Essential missing values, e.g. temperature.
结局指标
主要结局
The Registry is a questionnaire, containing 252 variables divided into a demographical, prehospital, hospital and outcome section. The collected measurement data will be registered on REDCap.
时间窗: through study completion, an average of 1 year
For every patient, the questionnaire on REDCap will be filled in. Demographical data contain age, weight, consent status, ... . Prehospital data include the prehospital temperature, the circumstances of the accident (drowning, avalanche, intoxication, ... ), the presence of cardiac arrest, the first heart rhythm, ... . Hospital data contain the rewarming mode, the complications after and during rewarming. Outcome data cover the cerebral performance category after hospitalisation. Every further study with their specific outcomes using the data of the International Hypothermia Registry will be registered separately on clinical trials.gov. The data that are necessary to answer the scientific question defined in further studies will be extracted from REDCap.
次要结局
未报告次要终点
研究者
Evelien Cools
Medical Doctor, Principal Investigator
University Hospital, Geneva