HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

Phase 1

• Conditions: Adult cardiac arrest patients with sustained ROSC and hemodynamic failure due to post-resuscitation syndrome; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-001620-33-FR
• Lead Sponsor: ASSISTANCE-PUBLIQUE HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-09
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 380

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 or emergency procedure

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 190

Exclusion Criteria

-Traumatic and 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 mechanical circulatory assistance
-Gastrointestinal bleeding in the past 6 weeks
-Pregnant or breastfeeding women
-Hypersensitivity to arginin-vasopressin and to its excipients
-Hypersensitivity to hydrocortisone and to its excipients
-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
-Legal protection (i.e. incompetence to provide consent, guardianship, curator or incarceration)
-No affiliation to a social security system

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified