Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early cessation of sedation and TTM.
- Who it may be relevant to
- Registry conditions: Hypoxia-Ischemia, Brain, Heart Arrest. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest: a Feasibility and Safety Study
Overview
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.
Interventions
- Other Early cessation of sedation and TTM
Early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate
Primary outcome measures
- 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 outcome measures (10)
- 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 [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) [Time frame: at 3 and 6 months]
- Neurological outcome measured at the Cerebral Performance Category (CPC) [Time frame: at 3 and 6 months]
- Cognitive functioning [Time frame: at 3 and 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 2 centers
- Rijnstate hospital — Arnhem
- Medisch Spectrum Twente — Enschede
Publications
- Bhat N, Amorim E. Cost-Effectiveness of EEG Monitoring in Hypoxic-Ischemic Brain Injury After Cardiac Arrest. J Clin Neurophysiol. 2026 Jul 1;43(5):423-431. doi: 10.1097/WNP.0000000000001261. Epub 2026 May 7. PMID 42359664
Identifiers
NCT: NCT06048796 · SELECT · NL84714.100.23