RecruitingPhase 3NCT04591990
HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome
HYdrocortisone and VAsopressin in Post-REsuscitation Syndrome
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
380 participants
Start Date
May 27, 2021
Study Type
INTERVENTIONAL
Conditions
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-cardiac arrest patients with hemodynamic failure.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria13
- 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.
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Interventions
DRUGAdministration of AVP
Administration of AVP
DRUGAdministration of placebo AVP
Administration of placebo AVP
DRUGAdministration of placebo hydrocortisone
Administration of placebo hydrocortisone
DRUGAdministration of hydrocortisone
Administration of hydrocortisone
Locations(14)
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NCT04591990