Defibrillation in Accidental Hypothermia

Sponsor

University Hospital, Geneva (Other)

Overall Status

Completed

CT.gov ID

NCT06131892

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia, Accidental Defibrillation	Other: Defibrillation

Study Design

Study Type:

Observational

Actual Enrollment :

63 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2023

Actual Primary Completion Date :

Sep 30, 2023

Actual Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Successful defibrillation during extra corporeal life support (ECLS) rewarming	Other: Defibrillation Defibrillation
Non Successful defibrillation during extra corporeal life support (ECLS) rewarming	Other: Defibrillation Defibrillation
Successful defibrillation before rewarming or during non-ECLS rewarming non- ECLS: non- extra corporeal life support	Other: Defibrillation Defibrillation
Non- successful defibrillation before rewarming or during non-ECLS rewarming non- ECLS: non- extra corporeal life support	Other: Defibrillation Defibrillation

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Anaesthesiology	Geneva		Switzerland

Sponsors and Collaborators

University Hospital, Geneva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Evelien Cools, Medical Doctor, Principal Investigator, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT06131892

Other Study ID Numbers:

2023-01087

First Posted:

Nov 14, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypothermia

Study Results

No Results Posted as of Nov 18, 2023