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).
Comatose patients after cardiac arrest are treated on intensive care units with sedative medication, targeted temperature management (TTM), mechanical ventilation, and hemodynamic support. Despite substantial variation in the severity of the encephalopathy and even lack of unequivocal evidence of efficacy of sedation and TTM, all patients receive standard treatment. The severity of the postanoxic encephalopathy can reliably be assessed with the electroencephalogram (EEG). A continuous EEG pattern within the first 12 hours after cardiac arrest ("favorable EEG") is strongly associated with a good neurological outcome and reflects a very mild or transient encephalopathy. The investigators hypothesize that this subgroup of patients, with a favorable EEG will not benefit from prolonged sedation and TTM. 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. The study design is a cluster randomized crossover design with two treatment arms. The intervention contrast will be early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate (intervention group) vs. standard care, including sedation and TTM for at least 24-48 hours (control group). The investigators will include forty adult patients admitted to the ICU with postanoxic encephalopathy after cardiac arrest and an early (\<12 hours) favorable EEG pattern.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate
Rijnstate hospital
Arnhem, Gelderland, Netherlands
RECRUITINGMedisch Spectrum Twente
Enschede, Overijssel, Netherlands
RECRUITINGMechanical 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).
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).
Total sedation time
Time frame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
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).
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).
Number of serious adverse events (SAEs)
Time frame: at 3 and 6 months
Mortality
Time frame: at 30 days, 3 months and 6 months
Complications during intensive care admission
Number of pneumonia, sepsis (according to sepsis 3 criteria), bleeding (any cause), cardiac arrhythmia (any associated with hemodynamic compromise), new cardiac arrest and thrombopenia
Time frame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Neurological outcome measured at the Extended Glasgow Outcome Scale (GOSE)
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The CPC ranges from 1 to 8, with higher scores meaning better neurological outcome.
Time frame: at 3 and 6 months
Neurological outcome measured at the Cerebral Performance Category (CPC)
The CPC ranges from 1 to 5, with higher scores meaning worse neurological outcome.
Time frame: at 3 and 6 months
Cognitive functioning
Montreal Cognitive Assessment (MOCA) score via videoconference. The MOCA ranges from 0 to 30, with higher scores meaning better cognitive functioning.
Time frame: at 3 and 6 months