International Registry of Accidental Hypothermia

Accidental Hypothermia Clinical Trial

— IHR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06200285
• Other study ID #: 2022-02000
• Status: Recruiting
• Start date: October 1, 2008
• Est. completion date: December 2054

Study information

• Verified date: December 2023
• Source: University Hospital, Geneva
• Contact: Evelien Cools, MD
• Phone: +41774191851
• Email: Evelien.Cools[@]hcuge.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2054
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Accidental Hypothermia
• Hypothermia

Intervention

Other:
• Registry of patients with accidental hypothermia

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck
Austria	Krankenhaus Barmherzige Brüder	Salzburg
Denmark	Rigshospitalet	Kopenhagen
Germany	Klinik Immenstadt	Immenstadt Im Allgäu
Italy	ASST Bergamo Est	Bergamo
Italy	EURAC Research	Bozen
Italy	Ospedale Santa Chiara	Trento
Japan	Hokkaido Ohno Memorial Hospital	Hokkaido
Poland	Medical University of Silesia	Katowice
Spain	Vall d'Hebron University Hospital	Barcelona
Spain	Hospital de Cerdanya	Girona
Switzerland	Kantonsspital Chür	Chur
Switzerland	Division of Anaesthesiology	Geneva
Switzerland	Osepedale Regionale di Lugano	Lugano
Switzerland	University Hospital Zürich	Zürich
United Kingdom	University of Portsmouth	Portsmouth

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Countries where clinical trial is conducted

Austria,  Denmark,  Germany,  Italy,  Japan,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year

External Links

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