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Study of Hydrocortisone and Vasopressin (Argipressin) Treatment in Adult Patients with Post-Cardiac Arrest Syndrome and Hemodynamic Failure

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What is this trial about?

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

This study focuses on patients with post-resuscitation syndrome, a condition that occurs after cardiac arrest when the heart has been restarted but patients experience blood pressure problems. The study examines the effectiveness of two medications: hydrocortisone (a steroid hormone) and argipressin (also known as vasopressin, a hormone that helps control blood pressure) compared to placebo in improving survival and brain function recovery.

The research aims to determine if using these medications together leads to better outcomes for patients who have survived cardiac arrest but are experiencing circulatory problems. The medications are given through intravenous methods - either as an injection or continuous infusion. Hydrocortisone is administered at doses up to 200 mg per day, while argipressin is given through continuous infusion for up to three days.

During the study, patients receive either the combination of both active medications or their matching placebos. The treatment continues for up to seven days for hydrocortisone and three days for argipressin. Patients' recovery is monitored for 30 days after treatment, with special attention to their brain function and overall survival. The medications are administered along with standard medical care that all patients receive in the intensive care unit.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    After experiencing cardiac arrest and being admitted to the intensive care unit (ICU), your condition will be evaluated

    Medical staff will check if your blood pressure is low and requires continuous medication through an IV line

    This assessment must occur within 24 hours after your heart has restarted

  2. Step 2

    Treatment initiation

    You will receive one of two possible treatment combinations through your IV line:

    Option 1: argipressin and hydrocortisone medications

    Option 2: placebo (inactive substance) instead of the medications

    The treatment must begin within 9 hours after starting blood pressure support medication

  3. Step 3

    Monitoring period - First week

    Daily heart function tests will be performed using ultrasound on days 1, 2, 3, and 7

    Blood tests will be taken at 48 and 72 hours to measure specific proteins in your blood

    Your kidney function and blood sugar levels will be regularly monitored

    Medical staff will track how long you need breathing support and blood pressure medications

  4. Step 4

    Extended monitoring - Day 30

    Your brain function will be evaluated using a special scale called the Glasgow Outcome Scale

    This assessment will occur either during a hospital visit if you are still admitted, or through a phone call if you have been discharged

    The medical team will record information about your recovery, including any complications that may have occurred

    Your total stay duration in the ICU and hospital will be documented

Who can join the trial?

10 criteria

  • Must be at least 18 years old
  • Must have experienced a cardiac arrest either in the hospital or outside the hospital
  • Must have achieved sustained return of spontaneous circulation (ROSC) lasting more than 30 minutes and been admitted to the Intensive Care Unit (ICU)
  • Must be experiencing post-resuscitation shock, which means:
    • Low blood pressure (systolic pressure below 90 mmHg or mean arterial pressure below 65 mmHg)
    • Not responding to fluid treatment
    • Occurring within 24 hours after heartbeat returns
    • Requiring continuous medication (norepinephrine or epinephrine) at a dose of at least 0.2 micrograms per kilogram per minute for 3 or more hours
    • Must start participation in the study within 9 hours of beginning norepinephrine treatment
    • Must have either:
      • Written informed consent from a legally authorized family member, or
      • Qualify for emergency procedure enrollment

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 85 years
  • Pregnant women or breastfeeding mothers
  • Known severe allergic reactions to vasopressin (a hormone that helps control blood pressure) or hydrocortisone (a steroid medication)
  • Terminal illness with life expectancy less than 6 months
  • Severe brain damage before cardiac arrest
  • Uncontrolled bleeding
  • Active treatment with steroids before cardiac arrest
  • Known severe liver disease
  • Known severe kidney disease requiring dialysis
  • Participation in another clinical trial within the last 30 days
  • Unable to provide informed consent (either directly or through legal representative)
  • More than 6 hours passed since return of spontaneous circulation (ROSC - when the heart starts beating on its own after cardiac arrest)
  • Severe chronic heart failure before cardiac arrest
  • Known autoimmune diseases (conditions where the body's immune system attacks its own tissues)
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Investigated drugs

  • Hydrocortisone

    is a steroid medication that helps reduce inflammation in the body and supports blood pressure regulation. It is commonly used in critical care situations to help stabilize patients who have experienced severe medical emergencies. This medication helps the body cope with stress and maintains proper blood pressure levels.

  • Vasopressin (AVP)

    is a hormone medication that helps constrict blood vessels and increase blood pressure. It is particularly useful in treating patients with low blood pressure after cardiac arrest. This medication helps maintain proper blood flow to vital organs when the body's natural regulatory systems are compromised.

What is already known about the treatment

  • Hydrocortisone

    A synthetic corticosteroid medication administered intravenously in critical care settings to treat severe inflammatory conditions and shock states. This steroid hormone acts by reducing inflammation and modulating the immune response at the cellular level, while also helping to maintain blood pressure and cardiovascular function. It belongs to the glucocorticoid class of medications and is particularly important in treating post-resuscitation syndrome by supporting hemodynamic stability and reducing systemic inflammation.

  • Vasopressin (AVP)

    A synthetic version of the natural hormone arginine vasopressin, administered intravenously in critical care settings to treat severe hypotension and shock states. This medication works by constricting blood vessels and increasing water reabsorption in the kidneys, helping to maintain blood pressure in critically ill patients. It belongs to the vasopressor class of medications and is particularly effective in post-cardiac arrest situations where conventional blood pressure support may be insufficient.

Investigated diseases

  • Post-resuscitation Syndrome

    A complex medical condition that occurs after successful resuscitation from cardiac arrest. It develops when blood circulation is restored after the heart starts beating again, causing a chain of processes in the body that can affect multiple organs. The syndrome typically involves problems with blood circulation, where blood vessels don't work properly, leading to unstable blood pressure. It can affect how well the heart pumps blood and may cause issues with other organs. The condition usually develops within the first few hours after resuscitation.

  • Cardiac Arrest

    A sudden stopping of the heart's pumping function, where the heart stops beating effectively and cannot pump blood to the rest of the body. During cardiac arrest, blood flow to vital organs ceases, and the person becomes unconscious and stops breathing normally. Without immediate intervention, the condition rapidly progresses and causes oxygen deprivation to the body's tissues. The event can be triggered by various underlying heart conditions or external factors.

  • Hemodynamic Failure

    A condition where the heart and blood vessels cannot maintain adequate blood flow to meet the body's needs. It involves problems with blood pressure, heart rate, or the amount of blood pumped by the heart. The condition can cause weakness, dizziness, and reduced blood flow to vital organs. This failure can develop gradually or occur suddenly, depending on the underlying cause.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516373-77-00Estimated enrolment380 patientsSponsorAssistance Publique Hopitaux De Paris

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