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)
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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