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HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

RecruitingPhase 3Ages 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

The primary objective is to demonstrate the superiority of arginine-vasopressin (AVP) and hydrocortisone compared with norepinephrine regarding day-30 survival and neurological recovery in post-cardiac arrest patients with hemodynamic failure.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients (\>18y) * Cardiac arrest (in-hospital or out-of-hospital) with sustained ROSC (\> 30 minutes) admitted to the ICU * Post-resuscitation shock defined as arterial hypotension (SAP \< 90 mmHg or MAP \< 65 mmHg) unresponsive to adequate fluid loading, which occurred within the first 24 hours after ROSC and requiring norepinephrine/epinephrine continuous infusion at a dose greater or equal to 0.2µg/kg/min for at least 3 hours * A maximal delay between the start of norepinephrine infusion and randomization of 9 hours * Informed written consent of the patient or a legally authorized close relative. Exclusion Criteria: * Evidence for a traumatic or a neurological cause of cardiac arrest * Shock due to uncontrolled haemorrhage * Previously known adrenal insufficiency * Limitation of life-sustaining therapies * Ongoing treatment by any steroids, whatever the dose * Ongoing extra-corporeal circulatory assistance * Gastrointestinal bleeding in the past 6 weeks * Pregnant or breastfeeding women * Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable * Hypersensitivity to arginin-vasopressin and to its excipients * Hypersensitivity to hydrocortisone and to its excipients * Legal protection (i.e. incompetence to provide consent, guardianship, curator or incarceration) * No affiliation with the French health care system.
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What it tests

  • Administration of AVP
  • Administration of placebo AVP
  • Administration of placebo hydrocortisone
  • Administration of hydrocortisone
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Where

14 sites
Intensive care unit, CHU Amiens- Picardie
Amiens, France
Intensive care unit, CHU Angers
Angers, France
Intensive care unit, CHI Robert Ballanger
Aulnay-sous-Bois, France
Medical Intensive Care Unit, Ambroise Paré hospital, APHP
Boulogne-Billancourt, France
Intensive care unit, CH public du Cotentin
Cherbourg, France
Intensive care unit, CHU Dijon
Dijon, France
Intensive care unit, Hospices civils de Lyon
Lyon, France
Intensive care unit, Hôpital Jacques Cartier
Massy, France

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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