Status:
RECRUITING
Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest
Lead Sponsor:
Medisch Spectrum Twente
Collaborating Sponsors:
Rijnstate Hospital
University of Twente
Conditions:
Hypoxia-Ischemia, Brain
Heart Arrest
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to estimate the feasibility and safety of early weaning from ICU treatment in patients after cardiac arrest and an early (\< 12 h) favourable EEG pattern (indicating no ...
Detailed Description
Comatose patients after cardiac arrest are treated on intensive care units with sedative medication, targeted temperature management (TTM), mechanical ventilation, and hemodynamic support. Despite sub...
Eligibility Criteria
Inclusion
- Patients after cardiac arrest admitted to the ICU for treatment with sedation, TTM and mechanical ventilation.
- Age 18 years or older.
- Continuous EEG measurement started within 12 hours after cardiac arrest.
- Favourable EEG pattern within 12 hours after arrest, defined as a continuous background pattern (NVN, 2019; Ruijter et al., 2019).
- Possibility to stop sedative treatment within three hours after identification of a favourable EEG pattern.
- Written informed consent (deferred).
Exclusion
- A known history of another medical condition with limited life expectancy (\<6 months).
- Any progressive brain illness, such as a brain tumour or neurodegenerative disease.
- Pre-admission Glasgow Outcome Scale Extended score of 4 or lower.
- Reason other than neurological condition to continue sedation and/or ventilation.
- Follow-up impossible due to logistic reasons.
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06048796
Start Date
March 12 2024
End Date
October 1 2026
Last Update
May 13 2024
Active Locations (2)
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1
Rijnstate hospital
Arnhem, Gelderland, Netherlands, 6815AD
2
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands, 7500KA