Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04591990

HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-12

380

Participants Needed

14

Research Sites

235 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients older than 18 years
  • Cardiac arrest (in-hospital or out-of-hospital) with sustained return of spontaneous circulation lasting more than 30 minutes admitted to the ICU
  • Post-resuscitation shock with low blood pressure (SAP < 90 mmHg or MAP < 65 mmHg) not responding to fluids, occurring within 24 hours after ROSC and requiring norepinephrine/epinephrine continuous infusion at a dose ≥ 0.2 µg/kg/min for at least 3 hours
  • Maximum delay between the start of norepinephrine infusion and randomization is 9 hours
  • Informed written consent from the patient or legally authorized close relative
Not Eligible

You will not qualify if you...

  • Cardiac arrest caused by trauma or neurological conditions
  • Shock caused by uncontrolled bleeding
  • Known adrenal insufficiency
  • Limitation of life-sustaining treatments
  • Current treatment with any steroids
  • Ongoing extracorporeal circulatory assistance
  • Gastrointestinal bleeding within the past 6 weeks
  • Pregnant or breastfeeding women
  • Participation in another interventional study or within an exclusion period after such a study
  • Allergic reaction to arginine-vasopressin or hydrocortisone or their components
  • Legal protection status preventing consent (guardianship, curator, incarceration)
  • No affiliation with the French health care system

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Intensive care unit, CHU Amiens- Picardie

Amiens, France

Actively Recruiting

2

Intensive care unit, CHU Angers

Angers, France

Actively Recruiting

3

Intensive care unit, CHI Robert Ballanger

Aulnay-sous-Bois, France

Actively Recruiting

4

Medical Intensive Care Unit, Ambroise Paré hospital, APHP

Boulogne-Billancourt, France, 92100

Withdrawn

5

Intensive care unit, CH public du Cotentin

Cherbourg, France

Actively Recruiting

6

Intensive care unit, CHU Dijon

Dijon, France

Actively Recruiting

7

Intensive care unit, Hospices civils de Lyon

Lyon, France

Actively Recruiting

8

Intensive care unit, Hôpital Jacques Cartier

Massy, France

Actively Recruiting

9

Intensive care unit, CHU Montpellier

Montpellier, France

Actively Recruiting

10

Intensive care unit, Brabois hospital

Nancy, France

Actively Recruiting

11

Intensive care unit, Hotel Dieu hospital

Nantes, France

Actively Recruiting

12

Intensive care unit, Clinique Ambroise Paré

Neuilly-sur-Seine, France, 92200

Actively Recruiting

13

Intensive care unit, Cochin hospital, APHP

Paris, France, 75014

Actively Recruiting

14

Intensive care unit, André Mignot hospital

Versailles, France

Actively Recruiting

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Research Team

G

Guillaume GERI, MD, PhD

CONTACT

A

Alain Cariou, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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