HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

NCT04591990 | Recruiting Phase 3 DMC

• 2 other identifiers: APHP2000332020-001620-33
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Postresuscitation Syndrome

Keywords

intensive care; hydrocortisone; vasopressin; post-resuscitation syndrome

Outcome Measures

Primary Outcomes (1)

• Neurological outcome

  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.

  at day-30

Secondary Outcomes (9)

• All-cause mortality

  at day-30

• Mortality attributed to irreversible hemodynamic failure

  at day-30

• Mortality attributed to neurological withdrawal of care

  at day-30

• Mortality attributed to comorbid withdrawal of care

  at day-30

• Day-30 brain death

  at day-30

Study Arms (4)

AVP + placebo hydrocortisone

EXPERIMENTAL

REVERPLEG® 40 IU/2mL+ Placebo of hydrocortisone.

Drug: Administration of AVP; Drug: Administration of placebo hydrocortisone

placebo AVP + hydrocortisone

EXPERIMENTAL

Placebo of REVERPLEG® 40 IU/2mL + Hydrocortisone 100mg UPJOHN®.

Drug: Administration of placebo AVP; Drug: Administration of hydrocortisone

AVP + hydrocortisone

EXPERIMENTAL

REVERPLEG® 40 IU/2mL + Hydrocortisone 100mg UPJOHN®.

Drug: Administration of AVP; Drug: Administration of hydrocortisone

placebo AVP + placebo hydrocortisone

EXPERIMENTAL

Placebo of REVERPLEG® 40 IU/2mL + placebo of hydrocortisone

Drug: Administration of placebo AVP; Drug: Administration of placebo hydrocortisone

Interventions

Administration of AVP DRUG

Administration of AVP

AVP + hydrocortisone; AVP + placebo hydrocortisone

Administration of placebo AVP DRUG

Administration of placebo AVP

placebo AVP + hydrocortisone; placebo AVP + placebo hydrocortisone

Administration of placebo hydrocortisone DRUG

Administration of placebo hydrocortisone

AVP + placebo hydrocortisone; placebo AVP + placebo hydrocortisone

Administration of hydrocortisone DRUG

Administration of hydrocortisone

AVP + hydrocortisone; placebo AVP + hydrocortisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (14)

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, 92100, 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, 92200, France

RECRUITING

Intensive care unit, Cochin hospital, APHP

Paris, 75014, France

RECRUITING

Intensive care unit, André Mignot hospital

Versailles, France

RECRUITING

Related Publications (2)

• Witten L, Gardner R, Holmberg MJ, Wiberg S, Moskowitz A, Mehta S, Grossestreuer AV, Yankama T, Donnino MW, Berg KM. Reasons for death in patients successfully resuscitated from out-of-hospital and in-hospital cardiac arrest. Resuscitation. 2019 Mar;136:93-99. doi: 10.1016/j.resuscitation.2019.01.031. Epub 2019 Jan 30.

  PMID: 30710595 BACKGROUND

• Geri G, Lascarrou JB, Levy B, Asfar P, Muller G, Legriel S, Ricome S, Cour M, Klouche K, Sauneuf B, Quenot JP, Bougouin W, Cariou A; HYVAPRESS investigators. Hydrocortisone and arginine vasopressin in post-resuscitation shock: the HYVAPRESS trial. Resusc Plus. 2025 May 19;24:100982. doi: 10.1016/j.resplu.2025.100982. eCollection 2025 Jul.

  PMID: 40503090 DERIVED

MeSH Terms

Conditions

Diabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Guillaume GERI, MD, PhD

  Intensive Care Unit, Clinique Ambroise Paré, 92200 Neuilly sur seine

  PRINCIPAL INVESTIGATOR

• Alain CARIOU, MD, PhD

  Medical Intensive Care Unit, Cochin Hospital, APHP, 75014 Paris

  STUDY DIRECTOR

Central Study Contacts

Guillaume GERI, MD, PhD

CONTACT

+33 (0) 6 69 24 22 47; dr.guillaume.geri@gmail.com

Alain Cariou, MD, PhD

CONTACT

+33 (0)1 58 41 25 01; alain.cariou@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: May 27, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)