HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

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.