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CompletedNCT06131892Updated Nov 18, 2023

Defibrillation in Accidental Hypothermia

An observational study in Hypothermia, Accidental and Defibrillation, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by University Hospital, Geneva · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
63
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hypothermia, Accidental
  • Defibrillation

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03

In context

Hypothermia

499 studies on the registry are indexed under Hypothermia; 53 are open to participants now.

This study's enrollment of 63 is below the median of 97 across 126 observational studies indexed under Hypothermia.

Browse Hypothermia studies →

Lead sponsor

University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with accidental hypothermia and a body core temperature equal or less than 30°C who had one or more defibrillation attempts

Inclusion criteria

  • patients of the International Hypothermia Registry with a defibrillation while having a body core temperature equal or less than 30°C

Exclusion criteria

Exclusion Criteria:

  • patients of the International Hypothermia Registry with a body core temperature >30°C
  • patients who refused to participate
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
63 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    non- ECLS: non- extra corporeal life support

    Other: Defibrillation

  • Non- successful defibrillation before rewarming or during non-ECLS rewarming

    non- ECLS: non- extra corporeal life support

    Other: Defibrillation

Interventions

  • OtherDefibrillation

    Defibrillation

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. the number of patients with a return to ventricular fibrillation after successful defibrillation

    Time frame: through study completion, an average of 3 months

  2. the rate of defibrillation attempts per patient

    Time frame: through study completion, an average of 3 months

  3. 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

    Time frame: through study completion, an average of 3 months

  4. 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

    Time frame: through study completion, an average of 3 months

07

Study locations

1 site
  • Division of Anaesthesiology
    Geneva, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06131892
Lead sponsor
University Hospital, Geneva
Responsible party
Evelien Cools (Medical Doctor, Principal Investigator, University Hospital, Geneva) — Principal investigator
First posted
Nov 14, 2023
Start date
Apr 1, 2023
Primary completion
Sep 30, 2023
Completion
Sep 30, 2023
Last update
Nov 18, 2023

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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