Defibrillation in Accidental Hypothermia

NCT06131892 | Completed

• 1 other identifier: 2023-01087
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia, Accidental; Defibrillation

Outcome Measures

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

  through study completion, an average of 3 months

Secondary Outcomes (4)

• 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

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

  through study completion, an average of 3 months

Study Arms (4)

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

Defibrillation OTHER

Defibrillation

Non Successful defibrillation during extra corporeal life support (ECLS) rewarming; Non- successful defibrillation before rewarming or during non-ECLS rewarming; Successful defibrillation before rewarming or during non-ECLS rewarming; Successful defibrillation during extra corporeal life support (ECLS) rewarming

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Division of Anaesthesiology

Geneva, Switzerland

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: November 14, 2023
• Study Start: April 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)