HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Postresuscitation Syndrome
In brief
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.
Key facts
- Study ID
- NCT04591990
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 380
- Starts
- 2021-05-27
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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.
Where it is running
- Intensive care unit, André Mignot hospital — Versailles, France (enrolling)
- Intensive care unit, CHU Angers — Angers, France (enrolling)
- Intensive care unit, CHI Robert Ballanger — Aulnay-sous-Bois, France (enrolling)
- Intensive care unit, CHU Amiens- Picardie — Amiens, France (enrolling)
- Intensive care unit, CH public du Cotentin — Cherbourg, France (enrolling)
- Intensive care unit, CHU Dijon — Dijon, France (enrolling)
- Intensive care unit, Hospices civils de Lyon — Lyon, France (enrolling)
- Intensive care unit, Hôpital Jacques Cartier — Massy, France (enrolling)
- Intensive care unit, CHU Montpellier — Montpellier, France (enrolling)
- Intensive care unit, Brabois hospital — Nancy, France (enrolling)
- Intensive care unit, Hotel Dieu hospital — Nantes, France (enrolling)
- Intensive care unit, Clinique Ambroise Paré — Neuilly-sur-Seine, France (enrolling)
- Intensive care unit, Cochin hospital, APHP — Paris, France (enrolling)
- Medical Intensive Care Unit, Ambroise Paré hospital, APHP — Boulogne-Billancourt, France
Full record on ClinicalTrials.gov
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