International Registry of Accidental Hypothermia

ConditionAccidental Hypothermia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorUniversity Hospital, Geneva

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

Patient opposition to be part of a study;

Essential missing values, e.g. temperature.

Trial population

The investigators aim to include patients of any age.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

Registry of patients with accidental hypothermia
Other intervention

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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.

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.

Time frame

through study completion, an average of 1 year