Hypothermia, AccidentalNCT06131892
Defibrillation in Accidental Hypothermia
An observational study of Hypothermia, Accidental and Defibrillation, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Hypothermia (core temperature ≤35°C) is a frequent and life-threatening complication after mountain accidents, near-drowning, and intoxications, and can provoke arrhythmia, reduced cardiac contractility, and cardiac arrest. The hypothermic heart may be insensitive to defibrillation with a core temperature <30°C. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypothermia, Accidental, Defibrillation
- What is being tested?
- Defibrillation
- How many people
- 63 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2023to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with accidental hypothermia and a body core temperature equal or less than 30°C who had one or more defibrillation attempts
Who may be able to join
- patients of the International Hypothermia Registry with a defibrillation while having a body core temperature equal or less than 30°C
Who cannot join
- patients of the International Hypothermia Registry with a body core temperature >30°C
- patients who refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defibrillation in Accidental Hypothermia: a Retrospective Study of the International Hypothermia Registry
Hypothermia (core temperature ≤35°C) is a frequent and life-threatening complication after mountain accidents, near-drowning, and intoxications, and can provoke arrhythmia, reduced cardiac contractility, and cardiac arrest. The hypothermic heart may be insensitive to defibrillation with a core temperature <30°C. Also, below <30°C after successful defibrillation, a perfusing rhythm often degenerates to ventricular fibrillation (VF) again. Repeated defibrillation can induce myocardial injury. Thus, the guidelines of the European Resuscitation Council (ERC) suggest delaying further defibrillation attempts until the core temperature is >30°C if VF persists after 3 shocks. Epinephrine should be withheld if core temperature is <30°C. Advanced Life Support (ALS) guidelines of the American Heart Association (AHA) state that it may be reasonable to perform further defibrillation attempts according to the standard algorithm and to consider administration of a vasopressor during cardiac arrest (Table 1). This discrepancy between ERC and AHA guidelines can be explained by the different interpretations of mainly animal data, which show that vasopressors increase the chances of successful defibrillation <30°C, defined as return of spontaneous circulation (ROSC) for at least 30 seconds. The guidelines of the Wilderness and Environmental Medicine Society (WMS) state that a single shock at a maximum power can be given for patients with a temperature <30°C.
The aim of this study is to evaluate clinical course of hypothermic patients(<30°C) undergoing defibrillation. The primary aim is to evaluate the success ratio of defibrillation, defined as ROSC for at least 30 seconds. Secondary aims are the recurrence rate of ventricular fibrillation, the number of defibrillation attempts per patient, the presence of cardiac dysfunction after defibrillation and the cerebral performance category (CPC) score at the end of hospitalization.
- Conditions
- Hypothermia, Accidental, Defibrillation
- Being tested
- Defibrillation
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefibrillationOther
Defibrillation
| Study group | Role | What they receive |
|---|---|---|
| Successful defibrillation during extra corporeal life support (ECLS) rewarming | Not described Receives: Other: Defibrillation | |
| Non Successful defibrillation during extra corporeal life support (ECLS) rewarming | Not described Receives: Other: Defibrillation | |
| Successful defibrillation before rewarming or during non-ECLS rewarming | non- ECLS: non- extra corporeal life support Receives: Other: Defibrillation | |
| Non- successful defibrillation before rewarming or during non-ECLS rewarming | non- ECLS: non- extra corporeal life support Receives: Other: Defibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patients with a core temperature equal or less than 30°C who had a successful defibrillation, defined as ROSC for at least 30 seconds
Measured: through study completion, an average of 3 months
Secondary outcomes (4)
the number of patients with a return to ventricular fibrillation after successful defibrillation
Measured: through study completion, an average of 3 months
the rate of defibrillation attempts per patient
Measured: through study completion, an average of 3 months
the number of patients with the presence of cardiac dysfunction after defibrillation
a decrease in cardiac output, or a reduced ejection fraction, systolic or diastolic dysfunction on echocardiographic ultrasound
Measured: through study completion, an average of 3 months
cerebral performance category (CPC) score of every patient at the end of hospitalization
a score from 1 to 5, with "1" meaning "Good Outcome", "5" means dead
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Apr 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypothermia, AccidentalStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 63 participants (actual)
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
- NCT06131892
- Sponsor's protocol ID
- 2023-01087
- Other IDs
- 2023
- Status last verified
- Nov 2023
- First submitted
- 22 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cools E, Blasco R, Paal P, Courvoisier DS, Zafren K, Brugger H, Rauch S, Walpoth B. Defibrillation in patients with accidental hypothermia and core temperatures </=30 degrees C - A retrospective observational study. Resuscitation. 2026 Feb;219:110971. doi: 10.1016/j.resuscitation.2026.110971. Epub 2026 Jan 20.
PubMed 41570880
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defibrillation in Accidental Hypothermia: a Retrospective Study of the International Hypothermia Registry
- ClinicalTrials.gov ID
- NCT06131892
- Acronym / sponsor ID
- 2023-01087
- Conditions
- Hypothermia, Accidental, Defibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 14 Nov 2023 (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.
Hypothermia (core temperature ≤35°C) is a frequent and life-threatening complication after mountain accidents, near-drowning, and intoxications, and can provoke arrhythmia, reduced cardiac contractility, and cardiac arrest. The hypothermic heart may be insensitive to defibrillation with a core temperature <30°C. Also, below <30°C after successful defibrillation, a perfusing rhythm often degenerates to ventricular fibrillation (VF) again. Repeated defibrillation can induce myocardial injury. Thus, the guidelines of the European Resuscitation Council (ERC) suggest delaying further defibrillation attempts until the core temperature is >30°C if VF persists after 3 shocks. Epinephrine should be withheld if core temperature is <30°C. Advanced Life Support (ALS) guidelines of the American Heart Association (AHA) state that it may be reasonable to perform further defibrillation attempts according to the standard algorithm and to consider administration of a vasopressor during cardiac arrest (Table 1). This discrepancy between ERC and AHA guidelines can be explained by the different interpretations of mainly animal data, which show that vasopressors increase the chances of successful defibrillation <30°C, defined as return of spontaneous circulation (ROSC) for at least 30 seconds. The guidelines of the Wilderness and Environmental Medicine Society (WMS) state that a single shock at a maximum power can be given for patients with a temperature <30°C.
The aim of this study is to evaluate clinical course of hypothermic patients(<30°C) undergoing defibrillation. The primary aim is to evaluate the success ratio of defibrillation, defined as ROSC for at least 30 seconds. Secondary aims are the recurrence rate of ventricular fibrillation, the number of defibrillation attempts per patient, the presence of cardiac dysfunction after defibrillation and the cerebral performance category (CPC) score at the end of hospitalization.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Successful defibrillation during extra corporeal life support (ECLS) rewarming | – | Other: Defibrillation |
| Non Successful defibrillation during extra corporeal life support (ECLS) rewarming | – | Other: Defibrillation |
| Successful defibrillation before rewarming or during non-ECLS rewarming | – | Other: Defibrillationnon- ECLS: non- extra corporeal life support |
| Non- successful defibrillation before rewarming or during non-ECLS rewarming | – | Other: Defibrillationnon- ECLS: non- extra corporeal life support |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with accidental hypothermia and a body core temperature equal or less than 30°C who had one or more defibrillation attempts
Key inclusion criteria (1 listed)
- patients of the International Hypothermia Registry with a defibrillation while having a body core temperature equal or less than 30°C
Key exclusion criteria (2 listed)
- patients of the International Hypothermia Registry with a body core temperature >30°C
- patients who refused to participate
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 |
|---|---|---|
| DefibrillationDefibrillation | Other | Non Successful defibrillation during extra corporeal life support (ECLS) rewarming, Non- successful defibrillation before rewarming or during non-ECLS rewarming, Successful defibrillation before rewarming or during non-ECLS rewarming, Successful defibrillation during extra corporeal life support (ECLS) rewarming |
Primary outcome
the number of patients with a core temperature equal or less than 30°C who had a successful defibrillation, defined as ROSC for at least 30 seconds
Time frame: through study completion, an average of 3 months
4 secondary outcomes
the number of patients with a return to ventricular fibrillation after successful defibrillation
Time frame: through study completion, an average of 3 months
the rate of defibrillation attempts per patient
Time frame: through study completion, an average of 3 months
the number of patients with the presence of cardiac dysfunction after defibrillation
Time frame: through study completion, an average of 3 months
cerebral performance category (CPC) score of every patient at the end of hospitalization
Time frame: through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 41570880Cools E, Blasco R, Paal P, Courvoisier DS, Zafren K, Brugger H, Rauch S, Walpoth B. Defibrillation in patients with accidental hypothermia and core temperatures </=30 degrees C - A retrospective observational study. Resuscitation. 2026 Feb;219:110971. doi: 10.1016/j.resuscitation.2026.110971. Epub 2026 Jan 20.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia, Accidental and Defibrillation, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of patients with a core temperature equal or less than 30°C who had a successful defibrillation, defined as ROSC for at least 30 seconds (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06131892, which also lists 1 linked publication.
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 18 Nov 2023.