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RecruitingNCT06200285IHRUpdated Jan 11, 2024

International Registry of Accidental Hypothermia

An observational study in Accidental Hypothermia, sponsored by University Hospital, Geneva. Recruiting at 16 sites in 9 countries. Per ClinicalTrials.gov, last updated 2024-01-11.

Sponsored by University Hospital, Geneva · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
500
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Accidental Hypothermia

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Keywords

  • Accidental Hypothermia
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The investigators aim to include patients of any age.

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

Exclusion Criteria:

  • Patient opposition to be part of a study;
  • Essential missing values, e.g. temperature.
04

Study design

Observational model
Other
Time perspective
Other
Enrollment
500 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples without dna

Interventions

  • OtherRegistry of patients with accidental hypothermia
05

What researchers measure

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.

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

06

Study locations

13 of 16 sites recruiting
  • Medical University Innsbruck
    Innsbruck, Austria
    Recruiting
  • Krankenhaus Barmherzige Brüder
    Salzburg, Austria
    Recruiting
  • Rigshospitalet
    Kopenhagen, Denmark
    Recruiting
  • Klinik Immenstadt
    Immenstadt Im Allgäu, Germany
    Active, not recruiting
  • ASST Bergamo Est
    Bergamo, Italy
    Recruiting
  • EURAC Research
    Bozen, 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
    • Evelien Cools, MD · Contact · Evelien.Cools@hcuge.ch · 0041774191851
    • Delphine Courvoisier, PD · Sub investigator
    • Beat Walpoth, PD · Sub investigator
    • Martin Tramèr, PD · Sub investigator
    Recruiting
  • Osepedale Regionale di Lugano
    Lugano, Switzerland
    Recruiting
  • University Hospital Zürich
    Zürich, Switzerland
    Recruiting
  • University of Portsmouth
    Portsmouth, United Kingdom
    Active, not recruiting
07

References and documents

Related links

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06200285
Lead sponsor
University Hospital, Geneva
Responsible party
Evelien Cools (Medical Doctor, Principal Investigator, University Hospital, Geneva) — Principal investigator
First posted
Jan 11, 2024
Start date
Oct 1, 2008
Primary completion
Jul 2020
Completion
Dec 2054 (estimated)
Last update
Jan 11, 2024

Study contacts

Evelien Cools, MD
Contact
Evelien.Cools@hcuge.ch
+41774191851
Beat Walpoth, PD
Contact
Beat.Walpoth@unige.ch
+41793300900

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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