Status:

RECRUITING

HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Postresuscitation Syndrome

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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-cardia...

Detailed 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 in...

Eligibility Criteria

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.

Key Trial Info

Start Date :

May 27 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

380 Patients enrolled

Trial Details

Trial ID

NCT04591990

Start Date

May 27 2021

End Date

December 1 2025

Last Update

June 12 2025

Active Locations (14)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (14 locations)

1

Intensive care unit, CHU Amiens- Picardie

Amiens, France

2

Intensive care unit, CHU Angers

Angers, France

3

Intensive care unit, CHI Robert Ballanger

Aulnay-sous-Bois, France

4

Medical Intensive Care Unit, Ambroise Paré hospital, APHP

Boulogne-Billancourt, France, 92100