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Dexmedetomidine for Neuroprotection in Adults After Out‑of‑Hospital Cardiac Arrest – Randomized Placebo‑Controlled Phase II Trial

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients who have experienced Cardiac Arrest outside of a hospital. After the heart is restarted, the brain can be injured because of lack of oxygen. The trial tests whether the sedative drug dexmedetomidine, given by IV infusion, can reduce this brain injury compared with a simple salt solution used as a placebo. The drug works by calming the nervous system, which may help protect brain cells during the critical period after the heart stops.

The purpose of the study is to see if the drug improves brain outcomes after out‑of‑hospital cardiac arrest. Participants are randomly assigned to receive either the study drug or the placebo and are monitored for three days. Blood samples are taken to measure levels of neuron-specific enolase and S100ß, both proteins that increase when brain cells are damaged, as well as other routine lab tests. The study records whether patients survive the first 72 hours and tracks any signs of organ problems during that time.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and Assignment

    After joining the study, you will be randomly placed into one of two groups. One group receives the test medication, dexmedetomidine, and the other group receives a placebo, which is a standard saline solution. Randomization ensures that the assignment is unbiased.

  2. Step 2

    Start of Intravenous Infusion

    Within a short time after randomization, an intravenous (IV) line will be placed and the assigned infusion will begin.

    If you are in the dexmedetomidine group, the infusion will contain dexmedetomidine at a dose of 0.5 µg per kilogram of body weight. The medication is delivered continuously through the IV line.

    If you are in the placebo group, the infusion will contain 60 ml of 0.9 % sodium chloride solution (normal saline) delivered in the same manner.

  3. Step 3

    Continuous Monitoring During Infusion

    While the infusion is running, medical staff will continuously monitor your heart rate, blood pressure, breathing, and level of sedation to ensure safety.

    Intravenous infusion means the medication is given directly into a vein, allowing rapid distribution throughout the body.

    The infusion will be continued for up to 72 hours after the cardiac arrest, unless a medical reason requires it to be stopped earlier.

  4. Step 4

    Blood Sample Collection for Biomarker Testing

    Blood samples will be taken at three specific times: 24 hours, 48 hours, and 72 hours after the cardiac arrest.

    These samples are analyzed for several substances that indicate brain injury and inflammation, such as neuron‑specific enolase (NSE), S100ß protein, C‑reactive protein (CRP), interleukin‑6 (IL‑6), and troponin T.

    The purpose of these tests is to compare how the test medication and the placebo affect the levels of these markers.

  5. Step 5

    Assessment of Primary Outcome at 72 Hours

    At the 72‑hour mark, the study will evaluate two main outcomes: whether death has occurred and the concentration of NSE in the blood.

    These results are combined into a ranked score that helps determine if dexmedetomidine provides a protective effect on the brain compared with the placebo.

  6. Step 6

    Completion of Study Medication

    After the 72‑hour assessment, the infusion is stopped for all participants.

    No further study medication is given, and you will continue to receive standard medical care as directed by your treating physicians.

Who can join the trial?

6 criteria

  • You are an adult (18 years or older) who experienced a heart stopping outside of a hospital, known as an out‑of‑hospital cardiac arrest.
  • Your circulation was restored and stayed stable for at least 20 minutes, either by your own heart restarting (return of spontaneous circulation or ROSC) or with a machine that takes over the heart’s work (extracorporeal cardiopulmonary resuscitation or eCPR), and this happened within 90 minutes after you collapsed.
  • You are in a coma (not awake) when you arrive at the hospital, which means a score on the Glasgow Coma Scale is less than 8, or doctors think you are in a coma because you are receiving medicines that make you sleepy (sedatives).
  • The study drug can be started within 2 hours after you are admitted to the hospital.
  • Your body temperature is being carefully controlled (kept at a specific temperature) as part of your treatment.
  • The combined time when your brain had no blood flow (no‑flow) and when blood flow was very low (low‑flow) adds up to at least 10 minutes.

Who cannot join the trial?

12 criteria

  • You cannot join the study if doctors expect you to die within the next 72 hours (3 days) or if you have a known illness that means you are likely to live less than three months.
  • You cannot join if you have a known allergy or intolerance to any of the medicines that will be used in the trial.
  • You cannot join if you need emergency (acute) surgery at the time you are being screened for the study.
  • You cannot join if you are pregnant or are breastfeeding a baby.
  • You cannot join if you have a “Do Not Resuscitate” or “Allow Natural Death” order, or any other limitation that prevents full intensive‑care treatment.
  • You cannot join if you have an advanced directive that says you do not want resuscitation, intensive‑care measures, or participation in a clinical trial.
  • You cannot join if your brain function before the cardiac arrest was rated as a CPC score of 3 or 4 (CPC is a scale that measures brain damage; 3‑4 means severe damage).
  • You cannot join if you have diseases that could affect the brain‑injury tests, such as cancer, severe inflammation, active bleeding, stroke, or an infection of the central nervous system (the brain or spinal cord).
  • You cannot join if the time from the heart stopping to when blood flow was restored was longer than 90 minutes (sustained circulation time > 90 min).
  • You cannot join if the period with no blood flow (no‑flow time) was longer than 10 minutes.
  • You cannot join if the cardiac arrest was not witnessed, unless doctors can be sure the no‑flow time was less than 10 minutes.
  • You cannot join if your blood pressure or breathing is so unstable that they cannot be controlled even with medicines that raise blood pressure (vasopressors) or machines that help the heart (mechanical circulatory support), indicating hemodynamic and respiratory instability.
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Investigated drugs

dexmedetomidine is a medication given through an IV line that acts as a calming and sleep‑inducing agent. In this study it is being tested to see if it can protect the brain and improve recovery in people who have had a cardiac arrest outside the hospital. By gently reducing the brain’s activity, the drug may lower the amount of damage that occurs after the heart stops and restarts, helping patients survive and have better neurologic outcomes.

What is already known about the treatment

  • Kochsalz "Braun" 0,9 % - Infusionslösung

    This medication is given as an intravenous infusion of a clear liquid that contains sodium chloride, commonly known as normal saline. It is a standard electrolyte solution that is widely used in hospitals for fluid replacement and as a control in clinical studies. The solution works by providing sodium and chloride ions to help keep the body’s fluid balance normal, without any specific drug effect. It is classified as an electrolyte solution (ATC code B05BB01).

  • Dexdor 100 micrograms/ml concentrate for solution for infusion

    This drug is administered by intravenous infusion, delivering dexmedetomidine directly into the bloodstream. Dexmedetomidine is already approved for use as a sedative in intensive‑care patients and for procedural sedation, and it is now being tested for possible brain‑protective effects after cardiac arrest. It works by selectively activating alpha‑2 receptors in the brain, which reduces the activity of the nervous system and helps lower stress and pain. Pharmacologically, it belongs to the class of central alpha‑2 adrenergic agonists (ATC code N05CM18).

Investigated diseases

Cardiac Arrest - Cardiac arrest is an abrupt stop of the heart’s pumping action, causing immediate loss of blood flow to the brain and other vital organs. The event results in sudden loss of consciousness and cessation of normal breathing. Without restoration of heart activity, the lack of circulation leads to progressive cellular injury in the brain, heart, kidneys, and liver. As time passes, these organs can develop dysfunction due to oxygen deprivation. The condition therefore evolves from a brief loss of circulation to increasingly severe organ impairment if circulation is not re‑established. Monitoring of biochemical markers such as neuron‑specific enolase, S100ß, troponin, and inflammatory proteins reflects the extent of this progression.
Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-527007-21-00Estimated enrolment100 patientsSponsorMedical University Of Vienna

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