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Recruiting Phase 3

HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

NCT04591990 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2021-05-27
Last updated
2025-06-12

Condition(s) studied

Postresuscitation Syndrome

Investigational drug(s) / intervention(s)

Administration of AVPAdministration of placebo AVPAdministration of placebo hydrocortisoneAdministration of hydrocortisone

Administration of AVP: Administration of AVP

Administration of placebo AVP: Administration of placebo AVP

Administration of placebo hydrocortisone: Administration of placebo hydrocortisone

Administration of hydrocortisone: Administration of hydrocortisone

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Neurological outcome — at day-30
    The primary endpoint will be the good neurological outcome at day-30. This will be evaluated using the Glasgow Outcome Scale (GOS, addendum 18.5.1) dichotomized as follow: good neurological outcome for categories 4 and 5 and poor neurological outcome or death for categories 3, 2 and 1. The GOS will be obtained at day-30 from an in-hospital visit if the patient is still hospitalized or from telephone contact with patients, relatives or general practitioners.

Trial sites (14)

FacilityCityRegionStatus
Intensive care unit, CHU Amiens- Picardie Amiens France Recruiting
Intensive care unit, CHU Angers Angers France Recruiting
Intensive care unit, CHI Robert Ballanger Aulnay-sous-Bois France Recruiting
Medical Intensive Care Unit, Ambroise Paré hospital, APHP Boulogne-Billancourt France Withdrawn
Intensive care unit, CH public du Cotentin Cherbourg France Recruiting
Intensive care unit, CHU Dijon Dijon France Recruiting
Intensive care unit, Hospices civils de Lyon Lyon France Recruiting
Intensive care unit, Hôpital Jacques Cartier Massy France Recruiting
Intensive care unit, CHU Montpellier Montpellier France Recruiting
Intensive care unit, Brabois hospital Nancy France Recruiting
Intensive care unit, Hotel Dieu hospital Nantes France Recruiting
Intensive care unit, Clinique Ambroise Paré Neuilly-sur-Seine France Recruiting
Intensive care unit, Cochin hospital, APHP Paris France Recruiting
Intensive care unit, André Mignot hospital Versailles France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04591990 on ClinicalTrials.gov ↗ ← All trials in France