Defibrillation in Accidental Hypothermia

Completed

• Conditions: Hypothermia, Accidental; Defibrillation
• Interventions: Other: Defibrillation

• Registration Number: NCT06131892
• Lead Sponsor: University Hospital, Geneva

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Study First Submitted: 2023-10-22
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-12
• Study First Posted: 2023-11-14
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non Successful defibrillation during extra corporeal life support (ECLS) rewarming	Defibrillation	-
Non- successful defibrillation before rewarming or during non-ECLS rewarming	Defibrillation	non- ECLS: non- extra corporeal life support
Successful defibrillation during extra corporeal life support (ECLS) rewarming	Defibrillation	-
Successful defibrillation before rewarming or during non-ECLS rewarming	Defibrillation	non- ECLS: non- extra corporeal life support

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
the number of patients with a return to ventricular fibrillation after successful defibrillation	through study completion, an average of 3 months
the rate of defibrillation attempts per patient	through study completion, an average of 3 months
the number of patients with the presence of cardiac dysfunction after defibrillation	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
cerebral performance category (CPC) score of every patient at the end of hospitalization	through study completion, an average of 3 months	a score from 1 to 5, with "1" meaning "Good Outcome", "5" means dead

Trial Locations

Locations (1)

Division of Anaesthesiology; 🇨🇭 Geneva, Switzerland