Informations générales (source: ClinicalTrials.gov)
HYdrocortisone and VAsopressin in Post-REsuscitation Syndrome (HYVAPRESS)
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mai 2021
décembre 2025
13 juin 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | GERI Guillaume | 18/04/2025 07:55:26 | Contacter | ||
| AP-HP - Hôpital Europeen Georges Pompidou | GERI Guillaume | 18/04/2025 07:55:26 | Contacter | ||
| AP-HP - Hôpital La Pitié-Salpêtrière | GERI Guillaume | 18/04/2025 07:55:26 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | GERI Guillaume | 18/04/2025 07:55:26 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| C.H. ROBERT BALLANGER | Contact (sur clinicalTrials) | ||||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Intensive care unit, Brabois hospital - Nancy - France | Contact (sur clinicalTrials) | ||||
| Intensive care unit, CH public du Cotentin - Cherbourg - France | Contact (sur clinicalTrials) | ||||
| Intensive care unit, CHU Amiens- Picardie - Amiens - France | Contact (sur clinicalTrials) | ||||
| Intensive care unit, CHU Angers - Angers - France | Contact (sur clinicalTrials) | ||||
| Intensive care unit, CHU Dijon - Dijon - France | Contact (sur clinicalTrials) | ||||
| Intensive care unit, CHU Montpellier - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Intensive care unit, Clinique Ambroise Paré - 92200 - Neuilly-sur-Seine - France | Contact (sur clinicalTrials) | ||||
| Intensive care unit, Hôpital Jacques Cartier - Massy - France | Contact (sur clinicalTrials) | ||||
| Intensive care unit, Hospices civils de Lyon - Lyon - France | Contact (sur clinicalTrials) | ||||
| Intensive care unit, Hotel Dieu hospital - Nantes - France | Contact (sur clinicalTrials) | ||||
| Medical Intensive Care Unit, Ambroise Paré Hospital, APHP - 92100 - Boulogne-Billancourt - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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.