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NCT Number: NCT06200285

International Registry of Accidental Hypothermia

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.

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Key information

Conditions

Accidental Hypothermia Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Innsbruck, Innsbruck, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Registry of patients with accidental hypothermia

Other

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.

Time frame: through study completion, an average of 1 year

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Beat Walpoth, PD

CONTACT

[email protected]

+41793300900

Evelien Cools, MD

CONTACT

[email protected]

+41774191851

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Acronym: IHR

Important dates

Study start: 2008
Primary completion: 2020
Study completion: 2054
First posted: Jan 11, 2024
Registry last updated: Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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