HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

Last updated: April 4, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Administration of placebo hydrocortisone

Administration of AVP

Administration of placebo AVP

Clinical Study ID

NCT04591990
APHP200033
2020-001620-33
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 < 65mmHg) unresponsive to adequate fluid loading, which occurred within the first 24hours after ROSC and requiring norepinephrine/epinephrine continuous infusion at adose 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 9hours

  • Informed written consent of the patient or a legally authorized close relative.

Exclusion

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 beingin 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 orincarceration)

  • No affiliation with the French health care system.

Study Design

Total Participants: 380
Treatment Group(s): 4
Primary Treatment: Administration of placebo hydrocortisone
Phase: 3
Study Start date:
May 27, 2021
Estimated Completion Date:
May 31, 2025

Study Description

For patients successfully resuscitated who got restoration of spontaneous circulation (ROSC) after cardiopulmonary resuscitation (CPR), the course is usually marked by a post-resuscitation syndrome including multiple organ failures of various intensity and anoxic brain damage. The cardiocirculatory failure usually dominates the clinical picture, and it often leads to multiorgan failure. This hemodynamic failure is multifactorial, including at various levels vasoplegia, myocardial dysfunction, endotoxin release and adrenal dysfunction and is at least partly related to a hormonal defect that could be counteracted by hormonal supplementation. Such a substitutive opotherapy by hydrocortisone and AVP could improve hemodynamic failure and decrease overall mortality in this setting.

This trial is a superiority multicentric trial and patients will be randomized in a 1:1:1:1 ratio using an electronic CRF.

Investigational medicinal products:

  • Arginin-vasopressin or AVP (REVERPLEG) The solution for infusion is prepared by diluting 40 I.U. REVERPLEG® with sodium chloride 9 mg/ml (0.9%) solution. The total volume after dilution should be 50 ml (equivalent to 0.8 I.U. AVP per ml).

AVP will be administered according to mean arterial pressure to target a 65mmHg blood pressure for max 3 days.

  • HYDROCORTISONE HEMISUCCINATE Vials with lyophilisate (100mg hydrocortisone) are provided by SERB laboratory. Hydrocortisone hemisuccinate will be administered as a 50mg intravenous bolus every 6 hours after an initial dose of 100mg, for 7 consecutive days. Stop of treatment by hydrocortisone will be performed without tapering.

Comparator treatment: placebos.

17 ICU centers in France will participate to this study targetting 380 patient's enrollment in the study.

Connect with a study center

  • Intensive care unit, CHU Amiens- Picardie

    Amiens,
    France

    Active - Recruiting

  • Intensive care unit, CHU Angers

    Angers,
    France

    Active - Recruiting

  • Intensive care unit, CHI Robert Ballanger

    Aulnay-sous-Bois,
    France

    Active - Recruiting

  • Medical Intensive Care Unit, Ambroise Paré hospital, APHP

    Boulogne-Billancourt, 92100
    France

    Site Not Available

  • Intensive care unit, CH public du Cotentin

    Cherbourg,
    France

    Active - Recruiting

  • Intensive care unit, CHU Dijon

    Dijon,
    France

    Active - Recruiting

  • Intensive care unit, Hospices civils de Lyon

    Lyon,
    France

    Active - Recruiting

  • Intensive care unit, Hôpital Jacques Cartier

    Massy,
    France

    Active - Recruiting

  • Intensive care unit, CHU Montpellier

    Montpellier,
    France

    Active - Recruiting

  • Intensive care unit, Brabois hospital

    Nancy,
    France

    Active - Recruiting

  • Intensive care unit, Hotel Dieu hospital

    Nantes,
    France

    Active - Recruiting

  • Intensive care unit, Clinique Ambroise Paré

    Neuilly-sur-Seine, 92200
    France

    Active - Recruiting

  • Intensive care unit, Cochin hospital, APHP

    Paris, 75014
    France

    Active - Recruiting

  • Intensive care unit, André Mignot hospital

    Versailles,
    France

    Active - Recruiting

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