Status:
COMPLETED
Prognostic Value of Ventricular Fibrillation Spectral Analysis in Sudden Cardiac Death
Lead Sponsor:
Hospital San Carlos, Madrid
Collaborating Sponsors:
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Hospital Universitario La Paz
Conditions:
Sudden Cardiac Death
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
Ventricular fibrillation (VF)-related sudden cardiac death (SCD) is a leading cause of mortality. Patients may survive with neurological damage despite state-of-the-art treatment. Current biological a...
Detailed Description
Trial design: The AWAKE trial is an investigator-initiated, multicenter, observational trial currently underway in 4 centers in Spain (Hospital Clínico San Carlos, Hospital Universitario La Paz, Hosp...
Eligibility Criteria
Inclusion
- In or out-of-hospital cardiac arrest with ventricular fibrillation (VF) as first documented rhythm.
- A ≥3-second VF tracings before the first direct current (DC) shock.
- Signed informed consent. Patients unable to consent, it will be requested to an authorized relative.
- Study group: GCS ≤8 and subject to temperature management (hypothermia 32-34ºC or normothermia 36ºC).
- Control group: GCS=15, thus no indication for temperature management.
Exclusion
- First documented rhythm other than VF (e.g. ventricular tachycardia, pulseless electrical activity, asystole)
- Unavailable or suboptimal quality of the ECG tracing before the first DC shock.
- Terminal disease or cognitive impairment before the SCD event.
- Other possible causes of comatose status different from SCD (e.g. drugs, traumatic brain injury, hypoxia).
- Aged under 18 .
- Unwilling to provide the informed consent.
- Comatose status (GCS≤8) and absence of temperature management or GCS ≥9 if temperature management was undertaken.
- Hemodynamic instability leading to incomplete 24 h of temperature management
- Early mortality and absence of subsequent withdrawal of sedation to assess cerebral performance.
Key Trial Info
Start Date :
June 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT03248557
Start Date
June 1 2016
End Date
March 1 2023
Last Update
March 7 2023
Active Locations (5)
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1
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain, 13005
2
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
3
Fundación Centro Nacional de Investigaciones Cardiovasculares, Carlos III
Madrid, Spain, 28029
4
Hospital Clínico San Carlos
Madrid, Spain, 28040