International Registry of Accidental Hypothermia (IHR)

December 27, 2023 updated by: Evelien Cools, University Hospital, Geneva

International Hypothermia Registry: a Registry With Worldwide Cases 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Innsbruck, Austria
        • Recruiting
        • Medical University Innsbruck
        • Contact:
      • Salzburg, Austria
        • Recruiting
        • Krankenhaus Barmherzige Brüder
        • Contact:
  • Denmark
  • Germany
      • Immenstadt Im Allgäu, Germany
        • Active, not recruiting
        • Klinik Immenstadt
  • Italy
      • Bergamo, Italy
        • Recruiting
        • ASST Bergamo Est
        • Contact:
      • Bozen, Italy
        • Recruiting
        • Eurac Research
        • Contact:
      • Trento, Italy
        • Active, not recruiting
        • Ospedale Santa Chiara
  • Japan
      • Hokkaido, Japan
        • Recruiting
        • Hokkaido Ohno Memorial Hospital
        • Contact:
  • Poland
      • Katowice, Poland
        • Recruiting
        • Medical University of Silesia
        • Contact:
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Vall d'Hebron University Hospital
        • Contact:
      • Girona, Spain
        • Recruiting
        • Hospital de Cerdanya
        • Contact:
  • Switzerland
      • Chur, Switzerland
      • Geneva, Switzerland
        • Recruiting
        • Division of Anaesthesiology
        • Contact:
        • Sub-Investigator:
          • Delphine Courvoisier, PD
        • Sub-Investigator:
          • Beat Walpoth, PD
        • Sub-Investigator:
          • Martin Tramèr, PD
      • Lugano, Switzerland
        • Recruiting
        • Osepedale Regionale di Lugano
        • Contact:
      • Zürich, Switzerland
        • Recruiting
        • University Hospital Zurich
        • Contact:
  • United Kingdom
      • Portsmouth, United Kingdom
        • Active, not recruiting
        • University of Portsmouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The investigators aim to include patients of any age.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2008

Primary Completion (Actual)

July 1, 2020

Study Completion (Estimated)

December 1, 2054

Study Registration Dates

First Submitted

November 12, 2023

First Submitted That Met QC Criteria

December 27, 2023

First Posted (Estimated)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-02000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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