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Recruiting NCT06200285

International Registry of Accidental Hypothermia

Observational Accidental Hypothermia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Registry of patients with accidental hypothermia.
Who it may be relevant to
Registry conditions: Accidental Hypothermia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Denmark, Germany, Italy, Japan +4
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

International Hypothermia Registry: a Registry With Worldwide Cases of Accidental Hypothermia

Overview

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.

Interventions

  • Other Registry of patients with accidental hypothermia

Primary outcome measures

  • 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. [Time frame: through study completion, an average of 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Switzerland · 4 centers
  • Kantonsspital Chür — Chur
  • Division of Anaesthesiology — Geneva
  • Osepedale Regionale di Lugano — Lugano
  • University Hospital Zürich — Zurich
Italy · 3 centers
  • ASST Bergamo Est — Bergamo
  • EURAC Research — Bolzano
  • Ospedale Santa Chiara — Trento
Austria · 2 centers
  • Medical University Innsbruck — Innsbruck
  • Krankenhaus Barmherzige Brüder — Salzburg
Spain · 2 centers
  • Vall d'Hebron University Hospital — Barcelona
  • Hospital de Cerdanya — Girona
Denmark · 1 center
  • Rigshospitalet — Copenhagen
Germany · 1 center
  • Klinik Immenstadt — Immenstadt im Allgäu
Japan · 1 center
  • Hokkaido Ohno Memorial Hospital — Hokkaido
Poland · 1 center
  • Medical University of Silesia — Katowice
United Kingdom · 1 center
  • University of Portsmouth — Portsmouth

Identifiers

NCT: NCT06200285 · 2022-02000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗