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NCT Number: NCT06048796

Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate hospital, Arnhem, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early cessation of sedation and TTM

Other

Early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. Total sedation time

    Time frame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).

  3. 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).

  4. 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).

  5. Number of serious adverse events (SAEs)

    Time frame: at 3 and 6 months

  6. Mortality

    Time frame: at 30 days, 3 months and 6 months

  7. 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).

    Number of pneumonia, sepsis (according to sepsis 3 criteria), bleeding (any cause), cardiac arrhythmia (any associated with hemodynamic compromise), new cardiac arrest and thrombopenia

  8. Neurological outcome measured at the Extended Glasgow Outcome Scale (GOSE)

    Time frame: at 3 and 6 months

    The CPC ranges from 1 to 8, with higher scores meaning better neurological outcome.

  9. Neurological outcome measured at the Cerebral Performance Category (CPC)

    Time frame: at 3 and 6 months

    The CPC ranges from 1 to 5, with higher scores meaning worse neurological outcome.

  10. Cognitive functioning

    Time frame: at 3 and 6 months

    Montreal Cognitive Assessment (MOCA) score via videoconference. The MOCA ranges from 0 to 30, with higher scores meaning better cognitive functioning.

Study contacts

Contact information is provided by the study sponsor or research team.

Marleen C. Tjepkema-Cloostermans, PhD

CONTACT

[email protected]

0031 534872850

Sponsors and collaborators

Lead sponsor

Medisch Spectrum Twente

Other

Collaborators

  • Rijnstate Hospital
  • University of Twente

Registry information

Official study title

Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest: a Feasibility and Safety Study

Acronym: SELECT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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