Viewing Study NCT06131892



Ignite Creation Date: 2024-05-06 @ 7:46 PM
Last Modification Date: 2024-10-26 @ 3:13 PM
Study NCT ID: NCT06131892
Status: COMPLETED
Last Update Posted: 2023-11-18
First Post: 2023-10-22

Brief Title: Defibrillation in Accidental Hypothermia
Sponsor: University Hospital Geneva
Organization: University Hospital Geneva

Study Overview

Official Title: Defibrillation in Accidental Hypothermia a Retrospective Study of the International Hypothermia Registry
Status: COMPLETED
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Hypothermia core temperature 35C 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 30C Also below 30C 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 30C if VF persists after 3 shocks Epinephrine should be withheld if core temperature is 30C 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 30C 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 30C

The aim of this study is to evaluate clinical course of hypothermic patients30C 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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None