Defibrillation in Accidental Hypothermia

Hypothermia, Accidental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06131892
• Other study ID #: 2023-01087
• Status: Completed
• Start date: April 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia, Accidental

Intervention

Other:
• Defibrillation
Defibrillation

Locations

Country	Name	City	State
Switzerland	Division of Anaesthesiology	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		through study completion, an average of 3 months
Secondary	the number of patients with a return to ventricular fibrillation after successful defibrillation		through study completion, an average of 3 months
Secondary	the rate of defibrillation attempts per patient		through study completion, an average of 3 months
Secondary	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	through study completion, an average of 3 months
Secondary	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	through study completion, an average of 3 months