Hypoxia-Ischemia, BrainSELECTNCT06048796
Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest
A study testing Early cessation of sedation and TTM in people with Hypoxia-Ischemia, Brain and Heart Arrest, run by Medisch Spectrum Twente at 2 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia-Ischemia, Brain, Heart Arrest
- What is being tested?
- Early cessation of sedation and TTM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNetherlands
- Study dates
- 12 Mar 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Rijnstate hospital
Arnhem, Gelderland, 6815AD
Jeannette Hofmeijer, Prof., +31 880058888, jhofmeijer@rijnstate.nl
- Recruiting
Medisch Spectrum Twente
Enschede, Overijssel, 7500KA
Marleen C. Tjepkema-Cloostermans+, PhD, +31 534872850, m.tjepkema-cloostermans@mst.nl
About this study
Official title: Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest: a Feasibility and Safety Study
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).
Read the 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.
- Conditions
- Hypoxia-Ischemia, Brain, Heart Arrest
- Being tested
- Early cessation of sedation and TTM
- Keywords
- EEG, targeted temperature management (TTM)
- Medical subject headings
- Hypoxia-Ischemia, Brain, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early cessation of sedation and TTMOther
Early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate
| Study group | Role | What they receive |
|---|---|---|
| Early cessation of sedation and TTM | Experimental | Early cessation of sedation and targeted temperature management (TTM), with subsequent weaning from mechanical ventilation if appropriate (intervention group). Receives: Other: Early cessation of sedation and TTM |
| Standard Care | No intervention | Standard care, including sedation and targeted temperature management (TTM) for at least 24-48 hours (control group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation time in hours
Measured: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Secondary outcomes (10)
Length of ICU stay
Measured: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Total sedation time
Measured: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Need for re-intubation
Measured: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Need for restarting sedation
Measured: 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)
Measured: at 3 and 6 months
Mortality
Measured: 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
Measured: 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)
The CPC ranges from 1 to 8, with higher scores meaning better neurological outcome.
Measured: 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.
Measured: 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.
Measured: at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start12 Mar 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoxia-Ischemia, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A cluster randomized crossover design with two treatment arms (early cessation from sedation and TTM vs standard care).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital, University of Twente
- Responsible party
- Principal investigator, Marleen Tjepkema-Cloostermans, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048796
- Sponsor's protocol ID
- SELECT
- Other IDs
- NL84714.100.23
- Acronym
- SELECT
- Status last verified
- May 2024
- First submitted
- 31 Aug 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 42359664
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest: a Feasibility and Safety Study
- ClinicalTrials.gov ID
- NCT06048796
- Acronym / sponsor ID
- SELECT / SELECT
- Conditions
- Hypoxia-Ischemia, Brain, Heart Arrest
- Keywords
- EEG, targeted temperature management (TTM)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Collaborators
- Rijnstate Hospital, University of Twente
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster randomized crossover design with two treatment arms (early cessation from sedation and TTM vs standard care).
| Arm | Type | Receives |
|---|---|---|
| Early cessation of sedation and TTM | Experimental | Other: Early cessation of sedation and TTMEarly cessation of sedation and targeted temperature management (TTM), with subsequent weaning from mechanical ventilation if appropriate (intervention group). |
| Standard Care | No intervention | –Standard care, including sedation and targeted temperature management (TTM) for at least 24-48 hours (control group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early cessation of sedation and TTMEarly cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate | Other | Early cessation of sedation and TTM |
Primary outcome
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).
10 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 42359664Bhat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early cessation of sedation and TTM in people with Hypoxia-Ischemia, Brain and Heart Arrest, run by Medisch Spectrum Twente at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marleen C. Tjepkema-Cloostermans, PhD (0031 534872850, m.tjepkema-cloostermans@mst.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06048796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.