Clinical trial NCT06200285: International Registry of Accidental Hypothermia
Official title: International Hypothermia Registry: a Registry With Worldwide Cases of Accidental Hypothermia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Accidental Hypothermia
Keywords: Accidental Hypothermia
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators aim to include patients of any age.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patient opposition to be part of a study;
* Essential missing values, e.g. temperature.

Primary outcomes:
measure: 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.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Salzburg
country: Austria
facility: Krankenhaus Barmherzige Brüder
city: Kopenhagen
country: Denmark
facility: Rigshospitalet
city: Immenstadt Im Allgäu
country: Germany
facility: Klinik Immenstadt
city: Bergamo
country: Italy
facility: ASST Bergamo Est
city: Bozen
country: Italy
facility: EURAC Research
city: Trento
country: Italy
facility: Ospedale Santa Chiara
city: Hokkaido
country: Japan
facility: Hokkaido Ohno Memorial Hospital
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
city: Girona
country: Spain
facility: Hospital de Cerdanya
city: Chur
country: Switzerland
facility: Kantonsspital Chür
city: Geneva
country: Switzerland
facility: Division of Anaesthesiology
city: Lugano
country: Switzerland
facility: Osepedale Regionale di Lugano
city: Zürich
country: Switzerland
facility: University Hospital Zürich
city: Portsmouth
country: United Kingdom
facility: University of Portsmouth
Study officials:
References: