International Registry of Accidental Hypothermia

NCT06200285 | Recruiting

• 1 other identifier: 2022-02000
• Study Type: observational
• Target: 500
• Locations: 9 countries
• Sites: 16

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.

Conditions

Accidental Hypothermia

Keywords

Accidental Hypothermia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Registry of patients with accidental hypothermia OTHER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators aim to include patients of any age.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (16)

Medical University Innsbruck

Innsbruck, Austria

RECRUITING

Krankenhaus Barmherzige Brüder

Salzburg, Austria

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Klinik Immenstadt

Immenstadt im Allgäu, Germany

ACTIVE NOT RECRUITING

ASST Bergamo Est

Bergamo, Italy

RECRUITING

EURAC Research

Bolzano, Italy

RECRUITING

Ospedale Santa Chiara

Trento, Italy

ACTIVE NOT RECRUITING

Hokkaido Ohno Memorial Hospital

Hokkaido, Japan

RECRUITING

Medical University of Silesia

Katowice, Poland

RECRUITING

Vall d'Hebron University Hospital

Barcelona, Spain

RECRUITING

Hospital de Cerdanya

Girona, Spain

RECRUITING

Kantonsspital Chür

Chur, Switzerland

RECRUITING

Division of Anaesthesiology

Geneva, Switzerland

RECRUITING

Osepedale Regionale di Lugano

Lugano, Switzerland

RECRUITING

University Hospital Zürich

Zurich, Switzerland

RECRUITING

University of Portsmouth

Portsmouth, United Kingdom

ACTIVE NOT RECRUITING

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood: Potassium, lactate, coagulation parameters, hemoglobin

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Evelien Cools, MD

CONTACT

+41774191851; Evelien.Cools@hcuge.ch

Beat Walpoth, PD

CONTACT

+41793300900; Beat.Walpoth@unige.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: January 11, 2024
• Study Start: October 1, 2008
• Primary Completion: July 1, 2020
• Study Completion (Estimated): December 1, 2054
• Last Updated: January 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); ES (2); AU (2); DK (1); PL (1); JP (1); CH (4); GB (1); IT (3)