International Registry of Accidental Hypothermia

NCT ID: NCT06200285

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-01

Study Completion Date

2054-12-31

Brief Summary

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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

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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

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Accidental Hypothermia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Registry of patients with accidental hypothermia

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Evelien Cools

Medical Doctor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

Krankenhaus Barmherzige Brüder

Salzburg, , Austria

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Klinik Immenstadt

Immenstadt im Allgäu, , Germany

Site Status ACTIVE_NOT_RECRUITING

ASST Bergamo Est

Bergamo, , Italy

Site Status RECRUITING

EURAC Research

Bolzano, , Italy

Site Status RECRUITING

Ospedale Santa Chiara

Trento, , Italy

Site Status ACTIVE_NOT_RECRUITING

Hokkaido Ohno Memorial Hospital

Hokkaido, , Japan

Site Status RECRUITING

Medical University of Silesia

Katowice, , Poland

Site Status RECRUITING

Vall d'Hebron University Hospital

Barcelona, , Spain

Site Status RECRUITING

Hospital de Cerdanya

Girona, , Spain

Site Status RECRUITING

Kantonsspital Chür

Chur, , Switzerland

Site Status RECRUITING

Division of Anaesthesiology

Geneva, , Switzerland

Site Status RECRUITING

Osepedale Regionale di Lugano

Lugano, , Switzerland

Site Status RECRUITING

University Hospital Zürich

Zurich, , Switzerland

Site Status RECRUITING

University of Portsmouth

Portsmouth, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Countries

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Austria Denmark Germany Italy Japan Poland Spain Switzerland United Kingdom

Central Contacts

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Evelien Cools, MD

Role: CONTACT

+41774191851

Beat Walpoth, PD

Role: CONTACT

+41793300900

Facility Contacts

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Peter Mair, PD

Role: primary

+43 512 90030

Peter Paal, PD

Role: primary

+4251250480448

Michael Wanscher

Role: primary

+45 35 45 35 45

Filippo Manelli

Role: primary

+39 035 306 1111

Simon Rauch, PD

Role: primary

+39 0471 055055

Kazue Oshiro, MD

Role: primary

+81 11-665-0020

Tomasz Darocha

Role: primary

+48 32 208 36 00

Robert Blasco, MD

Role: primary

+34 934 89 30 00

Inigo Soteras

Role: primary

+34 972 65 77 77

Frank Hillgärtner, MD

Role: primary

+41 81 256 61 11

Evelien Cools, MD

Role: primary

0041774191851

Alessandro Chiesa, MD

Role: primary

0918116111

Matthias Hilty, PD

Role: primary

044 255 11 11

Related Links

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Other Identifiers

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2022-02000

Identifier Type: -

Identifier Source: org_study_id

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