Skip to main content
OpenTrials
Completed

NCT Number: NCT06131892

Defibrillation in Accidental Hypothermia

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Anaesthesiology

Geneva, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Defibrillation

Other

Defibrillation

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

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

    a decrease in cardiac output, or a reduced ejection fraction, systolic or diastolic dysfunction on echocardiographic ultrasound

  4. cerebral performance category (CPC) score of every patient at the end of hospitalization

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

    a score from 1 to 5, with "1" meaning "Good Outcome", "5" means dead

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Defibrillation in Accidental Hypothermia: a Retrospective Study of the International Hypothermia Registry

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.