Actively Recruiting
Early Cessation of Sedation and Targeted Temperature Management in Patients With a Favorable EEG After Cardiac Arrest: A Feasibility and Safety Study
Led by Medisch Spectrum Twente · Updated on 2024-05-13
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medisch Spectrum Twente
Lead Sponsor
R
Rijnstate Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of early weaning from intensive care treatment in adult patients who have experienced cardiac arrest and show a favorable EEG pattern within the first 12 hours. This favorable EEG indicates no or mild brain injury after the arrest. The study aims to determine if early stopping of sedation and targeted temperature management (TTM) benefits this subgroup compared to standard care. The study uses a cluster randomized crossover design with two groups. One group receives early cessation of sedation and TTM, followed by weaning from mechanical ventilation if appropriate. The other group receives standard care with sedation and TTM continued for at least 24 to 48 hours. The study will include about forty patients admitted to the ICU with postanoxic encephalopathy and an early favorable EEG. Participants will be monitored during their ICU stay, with researchers measuring the total time on mechanical ventilation, length of ICU stay, sedation duration, and any need to restart sedation or re-intubate. Neurological outcomes, cognitive function, complications, serious adverse events, and mortality will be assessed up to six months after the cardiac arrest. The entire ICU admission period, up to 30 days, will be observed for these outcomes to evaluate safety and feasibility.
CONDITIONS
Brief Title
Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients after cardiac arrest admitted to the ICU for treatment with sedation, targeted temperature management, and mechanical ventilation.
- Age 18 years or older.
- Continuous EEG measurement started within 12 hours after cardiac arrest.
- Favorable EEG pattern within 12 hours after arrest, defined as a continuous background pattern.
- Possibility to stop sedative treatment within three hours after identification of a favorable EEG pattern.
- Written informed consent (deferred).
You will not qualify if you...
- Known history of another medical condition with limited life expectancy (less than 6 months).
- Any progressive brain illness, such as a brain tumor 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.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 12 hours after cardiac arrest
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person in ICU)
Duration - Up to 30 days or until ICU discharge
Participants receive either early cessation of sedation and targeted temperature management (TTM) with subsequent weaning from mechanical ventilation if appropriate, or standard care including sedation and TTM for at least 24-48 hours.
Continuous ICU monitoring during treatment period
Duration - Up to 6 months
Participants are monitored for safety and neurological outcomes after ICU discharge.
Assessments at 3 and 6 months post-treatment
Trial Site Locations
Total: 2 locations
1
Rijnstate hospital
Arnhem, Gelderland, Netherlands, 6815AD
Actively Recruiting
2
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands, 7500KA
Actively Recruiting
Research Team
M
Marleen C. Tjepkema-Cloostermans, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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