Clinical trial NCT06048796: Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest
Official title: Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest: a Feasibility and Safety Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxia-Ischemia, Brain
Heart Arrest
Keywords: EEG
targeted temperature management (TTM)
Lead sponsor: Medisch Spectrum Twente
Sponsor class: OTHER
Collaborators: name: Rijnstate Hospital
name: University of Twente
First posted: 2023-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster randomized crossover design with two treatment arms (early cessation from sedation and TTM vs standard care).
Primary purpose: TREATMENT

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 or mild postanoxic encephalopathy).

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Mechanical ventilation time in hours
timeFrame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Secondary outcomes:
measure: Length of ICU stay
timeFrame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
measure: Total sedation time
timeFrame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
measure: Need for re-intubation
timeFrame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
measure: Need for restarting sedation
timeFrame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
measure: Number of serious adverse events (SAEs)
timeFrame: at 3 and 6 months
measure: Mortality
timeFrame: at 30 days, 3 months and 6 months
measure: Complications during intensive care admission
timeFrame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
measure: Neurological outcome measured at the Extended Glasgow Outcome Scale (GOSE)
timeFrame: at 3 and 6 months
measure: Neurological outcome measured at the Cerebral Performance Category (CPC)
timeFrame: at 3 and 6 months
measure: Cognitive functioning
timeFrame: at 3 and 6 months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
state: Gelderland
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
Study officials:
References: