Accidental HypothermiaIHRNCT06200285
International Registry of Accidental Hypothermia
An observational study of Accidental Hypothermia, run by University Hospital, Geneva at 16 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Accidental Hypothermia
- What is being tested?
- Registry of patients with accidental hypothermia
- How many people
- 500 participants
- Where
- 16 sitesin 9 countries
- Study dates
- 1 Oct 2008to Dec 2054
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The investigators aim to include patients of any age.
Who may be able to join
- 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.
Who cannot join
- Patient opposition to be part of a study;
- Essential missing values, e.g. temperature.
Trial locations and contacts
16 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 9 countries
Switzerland4 sites, 4 recruiting
- Recruiting
Kantonsspital Chür
Chur
Frank Hillgärtner, MD, +41 81 256 61 11, frank.hillgaertner@ksgr.ch
- Recruiting
Division of Anaesthesiology
Geneva
Evelien Cools, MD, 0041774191851, Evelien.Cools@hcuge.ch
Delphine Courvoisier, PD
- Recruiting
Osepedale Regionale di Lugano
Lugano
Alessandro Chiesa, MD, 0918116111, Alessandro.Chiesa2@eoc.ch
- Recruiting
University Hospital Zürich
Zurich
Matthias Hilty, PD, 044 255 11 11, Matthias.Hilty@usz.ch
Italy3 sites, 2 recruiting
- Recruiting
ASST Bergamo Est
Bergamo
Filippo Manelli, +39 035 306 1111, f.manelli68@gmail.com
- Recruiting
EURAC Research
Bolzano
Simon Rauch, PD, +39 0471 055055, simon.rauch@eurac.edu
- Active, not recruiting
Ospedale Santa Chiara
Trento
Austria2 sites, 2 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck
Peter Mair, PD, +43 512 90030, p.mair@tirol-kliniken.at
- Recruiting
Krankenhaus Barmherzige Brüder
Salzburg
Peter Paal, PD, +4251250480448, Peter.Paal@icloud.com
Spain2 sites, 2 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona
Robert Blasco, MD, +34 934 89 30 00, roblasc.rb@gmail.com
- Recruiting
Hospital de Cerdanya
Girona
Inigo Soteras, +34 972 65 77 77, inigosoteras@yahoo.es
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Michael Wanscher, +45 35 45 35 45, micheal.wanscher@rh.regionh.dk
Japan1 site, 1 recruiting
- Recruiting
Hokkaido Ohno Memorial Hospital
Hokkaido
Kazue Oshiro, MD, +81 11-665-0020, kazooshiro@gmail.com
Poland1 site, 1 recruiting
- Recruiting
Medical University of Silesia
Katowice
Tomasz Darocha, +48 32 208 36 00, tomekdarocha@wp.pl
United Kingdom1 site
- Active, not recruiting
University of Portsmouth
Portsmouth
About this study
Official title: 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.
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.
- Conditions
- Accidental Hypothermia
- Being tested
- Registry of patients with accidental hypothermia
- Keywords
- Accidental Hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registry of patients with accidental hypothermiaOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Oct 2008
- Primary completionJul 2020
- Study completionDec 2054 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental HypothermiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evelien Cools, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200285
- Sponsor's protocol ID
- 2022-02000
- Acronym
- IHR
- Status last verified
- Dec 2023
- First submitted
- 12 Nov 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Hypothermia Registry: a Registry With Worldwide Cases of Accidental Hypothermia
- ClinicalTrials.gov ID
- NCT06200285
- Acronym / sponsor ID
- IHR / 2022-02000
- Conditions
- Accidental Hypothermia
- Keywords
- Accidental Hypothermia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Oct 2008 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Dec 2054 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators aim to include patients of any age.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient opposition to be part of a study;
- Essential missing values, e.g. temperature.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Registry of patients with accidental hypothermia | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accidental Hypothermia, run by University Hospital, Geneva at 16 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Switzerland, Italy, Austria, Spain, Denmark and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evelien Cools, MD (+41774191851, Evelien.Cools@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.