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Acetylcysteine versus glucose placebo for reducing oxidative stress in patients after out‑of‑hospital cardiac arrest (Phase II)

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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 an Out of Hospital Cardiac Arrest. After the heart starts beating again, the body can have damage from harmful molecules called free radicals. The trial is testing whether giving an infusion of acetylcysteine can lower this damage, compared with a simple sugar solution called placebo. The purpose of the study is to see if the medicine reduces the level of harmful changes in blood proteins that indicate oxidative stress.

Participants will be randomly assigned to receive one of two different doses of the medicine or the placebo, starting soon after the heart starts beating again. The infusion will be given through a vein and the participants will stay in the hospital for several days while blood samples are taken at set times to check for safety and any side effects. The study will end after the follow‑up period, and the collected data will be used to understand how the treatment works.

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 Treatment Assignment

    After enrollment, you are randomly assigned to receive either the study medication acetylcysteine or a placebo solution.

    The study medication is delivered by intravenous infusion, while the placebo consists of a 5 % glucose solution given by the same route.

  2. Step 2

    Administration of Study Infusion

    If you are assigned to the active group, you receive a single infusion of acetylcysteine at a total dose of 9600 mg.

    If you are assigned to the placebo group, you receive a single infusion of the 5 % glucose solution.

    Both infusions are administered through an intravenous line over a period determined by the clinical team.

  3. Step 3

    Immediate Monitoring for Reactions

    During and shortly after the infusion, clinical staff observe you for any signs of allergic rash, urticaria, angio‑edema, bronchospasm, or severe allergic reaction (anaphylaxis).

    Any observed reaction is recorded and managed according to standard medical practice.

  4. Step 4

    Blood Sampling Schedule

    Blood samples are taken at the following time points relative to the return of spontaneous circulation (ROSC):

    T0 – on admission (baseline),

    T1 – 12 hours after ROSC,

    T2 – 24 hours after ROSC,

    T3 – 48 hours after ROSC,

    T4 – 72 hours after ROSC.

    These samples are used to measure oxidative stress markers, inflammatory markers, and organ injury markers.

  5. Step 5

    Ongoing Safety Monitoring (First 48 Hours)

    For the first 48 hours after the infusion, you are continuously monitored for the occurrence of side effects such as allergic rash, urticaria, angio‑edema, clinically relevant bronchospasm, and severe allergic reaction (anaphylaxis).

    All observations are documented in the study records.

  6. Step 6

    Final Assessment and End of Study Participation

    At 72 hours after ROSC, the final set of blood samples is collected.

    After the last assessment, your participation in the trial is concluded, and you continue to receive standard medical care as determined by your treating physicians.

Who can join the trial?

4 criteria

  • Must have experienced an Out-of-Hospital Cardiac Arrest and currently be intubated (a breathing tube placed), unconscious or under sedation, with a Glasgow Coma Scale score less than 9 (a simple test that rates how awake a person is; lower numbers mean deeper unconsciousness).
  • Must be 18 years of age or older.
  • The study medication must be started within 4 hours after the heart begins beating on its own again, known as return of spontaneous circulation.
  • The cause of the cardiac arrest must be believed to be a heart problem (cardiac cause), whether the heart rhythm was shockable (can be treated with an electric shock) or non‑shockable, and whether it was due to a blockage (acute coronary syndrome) or another heart condition (non‑ischemic).

Who cannot join the trial?

10 criteria

  • Being part of another research study that tests a treatment
  • Weighing less than 40 kg (about 88 pounds)
  • Being in the intensive care unit (ICU) for end‑of‑life care or for organ donation
  • Being pregnant or breast‑feeding
  • Having a known allergy to NAC (the study drug) or any of its inactive ingredients
  • Receiving support from a machine called extracorporeal membrane oxygenation (ECMO), which helps the heart and lungs work
  • Using the medication nitroglycerin (NTG) at the same time
  • Having a heart arrest that is thought to be caused by something other than a heart problem (for example, a blood clot in the lungs, lack of oxygen, poisoning, or drowning)
  • Having sepsis, a serious infection that spreads throughout the body
  • Having severe asthma, a form of asthma that is difficult to control
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Investigated drugs

Acetylcysteine is a medication given through an IV infusion that helps protect cells from damage caused by oxidative stress. In this trial, it is being tested to see if it can lower the amount of harmful oxidative molecules in patients who have had a cardiac arrest outside the hospital. By reducing oxidative stress, the drug may improve recovery and lessen injury to the heart and other organs.

What is already known about the treatment

ACETYLCYSTEINE - This medication is given by intravenous infusion, where the drug is mixed in a fluid and delivered directly into a vein. It is an approved and well‑studied drug that is commonly used as a mucolytic (to thin mucus) and as an antidote for acetaminophen overdose, and it is also being investigated for reducing oxidative stress after cardiac arrest. It works by supplying cysteine, a building block that helps the body make glutathione, a natural antioxidant that protects cells from damage. In pharmacological terms, it is classified as a mucolytic and antioxidant agent (ATC code V03AB23).

Investigated diseases

Out-of-Hospital Cardiac Arrest (OHCA) - This condition occurs when the heart suddenly stops beating effectively outside of a medical facility, leading to loss of consciousness and absence of a pulse. Immediate cardiopulmonary resuscitation is required to restore blood flow. If circulation returns, the body experiences a period of reduced oxygen followed by reperfusion, which can cause inflammation and damage to multiple organs. The recovery phase may involve temporary heart muscle weakness, brain changes, and disturbances in blood chemistry as the body works to normalize function.
Trial detailsLast updated 25 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-525094-37-00Estimated enrolment105 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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