Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedisch Spectrum Twente
About this trial
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 or mild postanoxic encephalopathy).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Early cessation of sedation and TTM
Other interventionEarly cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Early cessation of sedation and TTMExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Mechanical ventilation time in hours
Time frame
During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).Secondary outcomes
1
Length of ICU stay
Time frame
During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).2
Total sedation time
Time frame
During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).3
Need for re-intubation
Time frame
During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).4
Need for restarting sedation
Time frame
During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).Sponsors and contacts
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Source ClinicalTrials.gov