Out-of-Hospital Cardiac ArrestNCT07895771
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
A study testing Minimal sedation and Standard continuous sedation in people with Out-of-Hospital Cardiac Arrest and Hypoxic-Ischemic Brain Injury, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury, Post-Cardiac Arrest Syndrome
- What is being tested?
- Minimal sedation and Standard continuous sedation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- 22 Sep 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana, Department of Intensive Internal Medicine
Ljubljana, 1000
Gašper Govekar, MD, +386 1 522 94 82, gasper.govekar@kclj.si
About this study
Official title: Effect of Early Discontinuation of Sedation on Biomarkers of Hypoxic-Ischemic Brain Injury After Out-of-Hospital Cardiac Arrest: A Prospective Randomized Non-Inferiority Trial
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.
Read the detailed description
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.
- Conditions
- Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury, Post-Cardiac Arrest Syndrome
- Being tested
- Minimal sedation, Standard continuous sedation
- Keywords
- sedation, neuron-specific enolase, targeted temperature management, intensive care, coma
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Hypoxia-Ischemia, Brain, Post-Cardiac Arrest Syndrome, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal sedationOther
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.
Standard continuous sedationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Sedation | Experimental | 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. Receives: Other: Minimal sedation |
| Standard Continuous Sedation | Active comparator | 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. Receives: Other: Standard continuous sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 72 hours after return of spontaneous circulation (ROSC)
Secondary outcomes (9)
In-hospital mortality
Death from any cause during the index hospitalization.
Measured: From hospital admission to hospital discharge, assessed up to 90 days
Length of hospital stay
Number of days from hospital admission to hospital discharge.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From randomization to ICU discharge, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start22 Sep 2026
- Primary completionSep 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomaž Goslar, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895771
- Sponsor's protocol ID
- SEDACIJA-OHCA-2026
- Other IDs
- 0120-19/2026-2711-4
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications (primary and secondary outcomes, baseline characteristics) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Discontinuation of Sedation on Biomarkers of Hypoxic-Ischemic Brain Injury After Out-of-Hospital Cardiac Arrest: A Prospective Randomized Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07895771
- Acronym / sponsor ID
- SEDACIJA-OHCA-2026
- Conditions
- Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury, Post-Cardiac Arrest Syndrome
- Keywords
- sedation, neuron-specific enolase, targeted temperature management, intensive care, coma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 26 Oct 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Sedation | Experimental | Other: Minimal sedationNo 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. |
| Standard Continuous Sedation | Active comparator | Other: Standard continuous sedationContinuous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| Minimal sedationSedation-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. | Other | Minimal Sedation |
| Standard continuous sedationContinuous 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. | Other | Standard Continuous Sedation |
Primary outcome
Serum neuron-specific enolase (NSE) concentration
Time frame: 72 hours after return of spontaneous circulation (ROSC)
Serum NSE concentration (micrograms/L) measured in the central hospital laboratory by electrochemiluminescence immunoassay; analysed as a continuous variable (log-transformed).
9 secondary outcomes
In-hospital mortality
Time frame: From hospital admission to hospital discharge, assessed up to 90 days
Length of hospital stay
Time frame: From hospital admission to hospital discharge, assessed up to 90 days
Neurological outcome at hospital discharge (Cerebral Performance Category)
Time frame: At hospital discharge, assessed up to 90 days
Duration of mechanical ventilation
Time frame: From ICU admission until successful liberation from mechanical ventilation, assessed up to 30 days
Length of ICU stay
Time frame: From ICU admission to ICU discharge, assessed up to 30 days
Area under the curve (AUC) of serum NSE
Time frame: 24, 48 and 72 hours after ROSC
Incidence of hyperthermia
Time frame: First 72 hours after ROSC or until return of consciousness, whichever occurs first
Incidence of seizures
Time frame: From randomization to ICU discharge, assessed up to 30 days
Protocol adherence
Time frame: From randomization to ICU discharge, assessed up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications (primary and secondary outcomes, baseline characteristics) will be shared upon reasonable request.
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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.
Tomaž Goslar, MD, PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal sedation and Standard continuous sedation in people with Out-of-Hospital Cardiac Arrest and Hypoxic-Ischemic Brain Injury, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gašper Govekar, MD (+386 1 522 94 82, gasper.govekar@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum neuron-specific enolase (NSE) concentration (time frame: 72 hours after return of spontaneous circulation (ROSC)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.