Early stopping of sedation and cooling treatment in patients with favorable EEG after cardiac arrest
Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest: a Feasibility and Safety Study
This study tests if stopping sedation and cooling treatment early in comatose patients with a good EEG after cardiac arrest can lead to better recovery compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medisch Spectrum Twente Academic / other |
| Locations | 2 sites (Arnhem, Gelderland and 1 other locations) |
| Trial ID | NCT06048796 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and safety of early cessation of sedation and targeted temperature management (TTM) in comatose patients who have experienced cardiac arrest and show a favorable EEG pattern within 12 hours. Patients will be randomly assigned to either an intervention group, where sedation and TTM will be stopped early, or a control group, which will receive standard care for 24-48 hours. The study will include forty adult patients and assess the impact of early treatment cessation on neurological outcomes. The hypothesis is that patients with a favorable EEG will not benefit from prolonged sedation and TTM.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been admitted to the ICU after cardiac arrest and show a favorable EEG pattern within 12 hours.
Not a fit: Patients with a known history of progressive brain illness or other medical conditions that limit life expectancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to quicker recovery times and reduced ICU stays for patients with favorable EEG patterns after cardiac arrest.
How similar studies have performed: While the approach of early cessation of sedation and TTM is innovative, similar studies have not been widely reported, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Arnhem, Gelderland and 1 other locations
- Rijnstate hospital — Arnhem, Gelderland, Netherlands (Recruiting)
- Medisch Spectrum Twente — Enschede, Overijssel, Netherlands (Recruiting)
Study contacts
- Study coordinator: Marleen C. Tjepkema-Cloostermans, PhD
- Email: m.tjepkema-cloostermans@mst.nl
- Phone: 0031 534872850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.