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Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest

RecruitingNAAges 18 Years - anyAllUniversity Medical Centre Ljubljana
NCT07895771 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Most patients resuscitated from out-of-hospital cardiac arrest (OHCA) remain comatose on hospital admission and are routinely managed with continuous sedation. Sedation facilitates temperature control, but deep and prolonged sedation is associated with longer mechanical ventilation, delirium, infections and delayed awakening. It is unknown whether minimizing sedation increases secondary hypoxic-ischemic brain injury. This single-centre, open-label, randomized non-inferiority trial will compare a minimal sedation strategy (no continuous sedation) with standard continuous sedation in 100 comatose adults after OHCA. The primary outcome is serum neuron-specific enolase (NSE) 72 hours after return of spontaneous circulation (ROSC). Secondary outcomes include in-hospital mortality, neurological outcome at discharge, duration of mechanical ventilation and length of ICU stay.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 years or older * Out-of-hospital cardiac arrest of presumed cardiac cause with return of spontaneous circulation (ROSC) * Comatose patient (FOUR score motor response below 4, or no verbal response to pain) Exclusion Criteria: * Time from ROSC to randomization more than 6 hours * Hypothermia (core body temperature 33 degrees C or lower at randomization) * Tonic-clonic seizures at randomization * Known severe neurological impairment before cardiac arrest (CPC 3-4) * Extracorporeal cardiopulmonary resuscitation (E-CPR) * Severe haemodynamic instability despite treatment: noradrenaline 0.6 micrograms/kg/min or more (or equivalent dose of another vasopressor) required to maintain MAP of 65 mmHg or more despite adequate fluid resuscitation * Difficult ventilation: FiO2 0.8 or more or PEEP 12 cmH2O or more required to achieve SpO2 of 90% or more or PaO2 of 8.0 kPa or more, or PaCO2 above 6.5 kPa despite optimized ventilation * Signs of raised intracranial pressure at randomization * Proven cervical spine injury * Pregnancy
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What it tests

  • Minimal sedation
  • Standard continuous sedation
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Where

1 site
University Medical Centre Ljubljana, Department of Intensive Internal Medicine
Ljubljana, Slovenia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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