Cardiac Arrest (CA)NCT06776302
Assessment of Brain Damage Using Monitoring of Cerebral Oximetry Dynamics in Patients After Cardiac Arrest
A study testing Raise of blood flow through the brain in people with Cardiac Arrest (CA), run by University Medical Centre Maribor at 1 site in Slovenia.
Trial summary
Sudden cardiac arrest is one of the leading causes of death in Europe. The recommended treatment for cardiac arrest is cardiopulmonary resuscitation (CPR) and electrical defibrillation with an automated external defibrillator (AED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA)
- What is being tested?
- Raise of blood flow through the brain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 May 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 over 18 years
- Out-of-hospital cardiac arrest
- Unconsciousness after return of spontaneous circulation (8 points or less on the Glasgow Coma Scale)
Who cannot join
- Intracranial hemorrhage (clinically suspected or proven by CT scan)
- Hypothermia (body temperature less than 32 degrees Celsius)
- Pregnancy
- Uncontrollable bleeding
- Uncontrollable blood pressure fluctuations
- Patient defined as palliative or terminal
- Cardiac arrest secondary to drowning, hypothermia, or trauma
Trial locations and contacts
1 site in 1 country.
About this study
Sudden cardiac arrest is one of the leading causes of death in Europe. The recommended treatment for cardiac arrest is cardiopulmonary resuscitation (CPR) and electrical defibrillation with an automated external defibrillator (AED).
The chain of survival, which connects all links of basic and additional resuscitation procedures and post-resuscitation care, is important for successful survival.
Read more
Most patients after out-of-hospital cardiac arrest die in intensive care units due to the withdrawal of active treatment, based on the prediction of a poor neurological outcome. Prognostic indicators are influenced by many factors, including the patient's neurological condition. This should be taken into account when predicting outcome and a multimodal approach based on clinical examination, electrophysiological examinations, imaging studies and biological markers should be used.
Based on the professional literature, we asked ourselves the research question of whether it is possible to achieve changes in cerebral oxygen saturation values using simple tests and whether such changes in cerebral oxygen saturation coincide with other methods used to assess neurological outcome and brain damage in patients after primary out-of-hospital cardiac arrest. The patient will have a device installed to detect cerebral oxygen saturation (NIRS) throughout the entire hospitalization period. The level of oxygen in the brain is influenced by various factors: mean arterial pressure, cardiac index, carbon dioxide level in the blood, hemoglobin level in the blood, depth of sedation, body temperature. We will attempt to achieve changes in cerebral oxygen saturation with two simple tests. The first test is based on increasing blood flow through the brain through a controlled gradual infusion of a drug that raises blood pressure. The patient will receive such an infusion immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission.
The second test is based on passive elevation of the lower extremities, which results in a transient increased cardiac index produced by the heart and a consequent increase in blood flow through the brain. The second test will also be performed on the patient immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission.
Based on the data obtained with the help of the aforementioned tests, we will not decide on the prognosis of the patient's neurological outcome or change or adjust the therapy in any way based on the data obtained.
The aim of the study is to demonstrate that changes in cerebral oxygen saturation values in patients after primary out-of-hospital cardiac arrest, obtained with simple tests, coincide with other methods used to assess neurological outcome and brain damage.
- Conditions
- Cardiac Arrest (CA)
- Being tested
- Raise of blood flow through the brain
- Keywords
- cardiac arrest, near infrared spectroscopy
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raise of blood flow through the brainDiagnostic test
At each patient two test are preformed. The first test is based on increasing blood flow through the brain through a controlled gradual infusion of norepinephrine (noradrenalin). The patient will receive such an infusion immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission. The second test is based on passive elevation of the lower extremities. The second test will also be performed on the patient immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission.
| Study group | Role | What they receive |
|---|---|---|
| Patients after cardiac arrest | Experimental | Patients after cardiac arrest, admited to department of Intensive internal medicine. Receives: Diagnostic Test: Raise of blood flow through the brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cerebral oximetry values in patients after out-of-hospital cardiac arrest, obtained with described tests
Measured: From enrollment to the 2 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 May 2024
- Primary completion1 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776302
- Sponsor's protocol ID
- UKC Maribor OIIM/UC/KN
- Status last verified
- Jul 2026
- First submitted
- 9 Jan 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Brain Damage Using Monitoring of Cerebral Oximetry Dynamics in Patients After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT06776302
- Acronym / sponsor ID
- UKC Maribor OIIM/UC/KN
- Conditions
- Cardiac Arrest (CA)
- Keywords
- cardiac arrest, near infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 15 Jan 2025 (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.
Sudden cardiac arrest is one of the leading causes of death in Europe. The recommended treatment for cardiac arrest is cardiopulmonary resuscitation (CPR) and electrical defibrillation with an automated external defibrillator (AED).
The chain of survival, which connects all links of basic and additional resuscitation procedures and post-resuscitation care, is important for successful survival.
Most patients after out-of-hospital cardiac arrest die in intensive care units due to the withdrawal of active treatment, based on the prediction of a poor neurological outcome. Prognostic indicators are influenced by many factors, including the patient's neurological condition. This should be taken into account when predicting outcome and a multimodal approach based on clinical examination, electrophysiological examinations, imaging studies and biological markers should be used.
Based on the professional literature, we asked ourselves the research question of whether it is possible to achieve changes in cerebral oxygen saturation values using simple tests and whether such changes in cerebral oxygen saturation coincide with other methods used to assess neurological outcome and brain damage in patients after primary out-of-hospital cardiac arrest. The patient will have a device installed to detect cerebral oxygen saturation (NIRS) throughout the entire hospitalization period. The level of oxygen in the brain is influenced by various factors: mean arterial pressure, cardiac index, carbon dioxide level in the blood, hemoglobin level in the blood, depth of sedation, body temperature. We will attempt to achieve changes in cerebral oxygen saturation with two simple tests. The first test is based on increasing blood flow through the brain through a controlled gradual infusion of a drug that raises blood pressure. The patient will receive such an infusion immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission.
The second test is based on passive elevation of the lower extremities, which results in a transient increased cardiac index produced by the heart and a consequent increase in blood flow through the brain. The second test will also be performed on the patient immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission.
Based on the data obtained with the help of the aforementioned tests, we will not decide on the prognosis of the patient's neurological outcome or change or adjust the therapy in any way based on the data obtained.
The aim of the study is to demonstrate that changes in cerebral oxygen saturation values in patients after primary out-of-hospital cardiac arrest, obtained with simple tests, coincide with other methods used to assess neurological outcome and brain damage.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after cardiac arrest | Experimental | Diagnostic Test: Raise of blood flow through the brainPatients after cardiac arrest, admited to department of Intensive internal medicine. |
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 over 18 years
- Out-of-hospital cardiac arrest
- Unconsciousness after return of spontaneous circulation (8 points or less on the Glasgow Coma Scale)
Key exclusion criteria (7 listed)
- Intracranial hemorrhage (clinically suspected or proven by CT scan)
- Hypothermia (body temperature less than 32 degrees Celsius)
- Pregnancy
- Uncontrollable bleeding
- Uncontrollable blood pressure fluctuations
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 |
|---|---|---|
| Raise of blood flow through the brainAt each patient two test are preformed. The first test is based on increasing blood flow through the brain through a controlled gradual infusion of norepinephrine (noradrenalin). The patient will receive such an infusion immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission. The second test is based on passive elevation of the lower extremities. The second test will also be performed on the patient immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission. | Diagnostic test | Patients after cardiac arrest |
Primary outcome
Changes in cerebral oximetry values in patients after out-of-hospital cardiac arrest, obtained with described tests
Time frame: From enrollment to the 2 days after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Arrest (CA)
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
RecruitingObservational study
Physiology-directed Epinephrine Dosing in Pediatric Cardiac Arrest
Cardiac Arrest (CA)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raise of blood flow through the brain in people with Cardiac Arrest (CA), run by University Medical Centre Maribor 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 7 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: finished, as of the sponsor's last update on 28 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cerebral oximetry values in patients after out-of-hospital cardiac arrest, obtained with described tests (time frame: From enrollment to the 2 days after admission). 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 28 Jul 2026.