Minimal Sedation After Out-of-Hospital Cardiac Arrest

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-centre, open-label randomized non-inferiority trial enrolling comatose adults after out-of-hospital cardiac arrest. Participants are assigned to either a minimal sedation strategy (no continuous sedation unless needed) or standard continuous sedation for at least 36 hours, with analgesia and active temperature management in both groups. The primary endpoint is serum NSE at 72 hours, with secondary outcomes including mortality, neurological status at discharge, duration of mechanical ventilation, and ICU length of stay. The study uses a web-based randomization system and follows a structured protocol for hyperthermia, shivering, seizures, and EEG monitoring over about two years. Lead site is University Medical Centre Ljubljana, Slovenia.

Why it matters

Who can join: the full rules

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

Where it's running

• University Medical Centre Ljubljana, Department of Intensive Internal Medicine
  Ljubljana, Slovenia Recruiting

Study contacts

• Principal investigator: Tomaž Goslar, MD, PhD — University Medical Centre Ljubljana
• Study coordinator: Gašper Govekar, MD
• Email: gasper.govekar@kclj.si
• Phone: +386 1 522 94 82

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Portable MRI to detect brain injury after cardiac arrest

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• Early double sequential defibrillation for cardiac arrest outside the hospital

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  Recruiting at 9 sites Phase 2/3 Karolinska Institutet · Amsterdam and 13 other locations · NCT07174986

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.