An interventional study of Minimal sedation and Standard continuous sedation in Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury and Post-Cardiac Arrest Syndrome, sponsored by University Medical Centre Ljubljana. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Treatment
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.
Design: prospective, interventional, randomized, open-label, single-centre non-inferiority trial at the Department of Intensive Internal Medicine, University Medical Centre Ljubljana, Slovenia, with a planned duration of approximately 2 years.
Randomization: after confirmation of eligibility, patients are randomized 1:1 to minimal sedation or standard continuous sedation using the web-based Sealed Envelope system with permuted blocks of variable size.
Minimal sedation group: continuous sedation is not started, or is stopped immediately after randomization. Short-acting sedatives may be used at the lowest possible dose for the shortest possible time when clinically required. Patients receive adequate analgesia throughout and are extubated when criteria for safe extubation are met.
Standard sedation group: continuous sedation and analgesia for at least 36 hours after cardiac arrest (propofol and sufentanil as first choice), titrated to PSI 25-50 or BIS 40-60; after 36 hours sedation may be discontinued at the discretion of the treating physician.
Both groups: adequate analgesia, prevention of hyperthermia (core temperature above 37.5 C) for 72 hours or until return of consciousness, RASS assessment every 6 hours, a stepwise protocol for hyperthermia and shivering (paracetamol, metamizole, magnesium, pethidine/chlorpromazine, intravascular cooling, NSAID, dexmedetomidine, propofol, rocuronium) and a protocol for seizures (lorazepam, levetiracetam, lacosamide). EEG is recorded on the first working day in patients without meaningful contact. Neuroprognostication follows current guidelines.
Sample size: based on log-transformed NSE values from retrospective institutional data (SD 1.1), a non-inferiority margin of 0.59 on the log scale, alpha 0.05 and 80% power, 44 patients per group are required; 50 per group (100 in total) will be enrolled to allow for dropouts. The primary analysis is a Student t-test on log-transformed NSE values.
328 studies on the registry are indexed under Out-of-Hospital Cardiac Arrest; 89 are open to participants now.
This study's planned enrollment of 100 is below the median of 219 across 184 interventional studies indexed under Out-of-Hospital Cardiac Arrest.
Browse Out-of-Hospital Cardiac Arrest studies →University Medical Centre Ljubljana is the lead sponsor of 294 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No continuous sedation. Continuous sedation is not started, or is stopped immediately after randomization. Short-acting sedatives may be given at the lowest possible dose for the shortest possible time if clinically required (procedures, agitation, escalation of hyperthermia/shivering treatment, seizures). Adequate analgesia throughout (paracetamol, metamizole, piritramide; sufentanil infusion if needed). Extubation when criteria for safe extubation are met.
Other: Minimal sedation
Continuous sedation and analgesia for at least 36 hours after cardiac arrest according to the institutional post-cardiac arrest protocol. Propofol is the first-choice sedative and sufentanil the first-choice analgesic, titrated to PSI 25-50 (Masimo) or BIS 40-60 (Medtronic). After 36 hours, sedation may be discontinued at the discretion of the treating physician.
Other: Standard continuous sedation
Sedation-minimizing strategy without continuous sedation: continuous sedation is not started or is stopped immediately after randomization; short-acting sedatives only when clinically required, at the lowest dose for the shortest time; analgesia maintained throughout.
Continuous sedation with propofol (first choice) and continuous analgesia with sufentanil (first choice) for at least 36 hours after cardiac arrest, titrated to PSI 25-50 or BIS 40-60; after 36 hours, sedation may be discontinued at the discretion of the treating physician.
Serum neuron-specific enolase (NSE) concentration
Serum NSE concentration (micrograms/L) measured in the central hospital laboratory by electrochemiluminescence immunoassay; analysed as a continuous variable (log-transformed).
Time frame: 72 hours after return of spontaneous circulation (ROSC)
In-hospital mortality
Death from any cause during the index hospitalization.
Time frame: From hospital admission to hospital discharge, assessed up to 90 days
Length of hospital stay
Number of days from hospital admission to hospital discharge.
Time frame: From hospital admission to hospital discharge, assessed up to 90 days
Neurological outcome at hospital discharge (Cerebral Performance Category)
Cerebral Performance Category (CPC) scale, range 1-5, where higher scores indicate worse outcome; good outcome defined as CPC 1-2 and poor outcome as CPC 3-5.
Time frame: At hospital discharge, assessed up to 90 days
Duration of mechanical ventilation
Number of days from start of invasive mechanical ventilation to first successful extubation (24 hours without invasive ventilation) or 24 hours of unassisted breathing via tracheostomy.
Time frame: From ICU admission until successful liberation from mechanical ventilation, assessed up to 30 days
Length of ICU stay
Number of days from ICU admission to ICU discharge (or the day the patient is ready for ICU discharge).
Time frame: From ICU admission to ICU discharge, assessed up to 30 days
Area under the curve (AUC) of serum NSE
Area under the time-concentration curve of serum NSE measured at 24, 48 and 72 hours after ROSC.
Time frame: 24, 48 and 72 hours after ROSC
Incidence of hyperthermia
Proportion of patients with at least one episode of core body temperature above 37.5 degrees C (urinary bladder or central venous catheter).
Time frame: First 72 hours after ROSC or until return of consciousness, whichever occurs first
Incidence of seizures
Proportion of patients with clinically recognised or EEG-confirmed seizures during ICU treatment.
Time frame: From randomization to ICU discharge, assessed up to 30 days
Protocol adherence
Proportion of patients treated fully according to the allocated protocol; reasons for deviations (hyperthermia, seizures, delirium or other acute neurological disorder, haemodynamic instability, technical limitations, physician decision) are recorded.
Time frame: From randomization to ICU discharge, assessed up to 30 days
Plan to share: Yes — De-identified individual participant data underlying the results reported in publications (primary and secondary outcomes, baseline characteristics) will be shared upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months after publication of the primary results and ending 5 years after publication.
Access criteria: Data will be shared with qualified researchers who submit a methodologically sound, justified proposal to the principal investigator. Requests are reviewed by the study investigators; sharing requires a signed data access agreement and compliance with applicable data protection regulations (GDPR) and ethics approval where required.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Sep 2028, 24 months after the start.
Of 92 non-industry interventional studies with no phase under Out-of-Hospital Cardiac Arrest, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 24 months is below that.
Counting every sponsor, half of 94 studies reached it within 38 months; a quarter within 19 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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