HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

  • STATUS
    Recruiting
  • End date
    May 23, 2023
  • participants needed
    380
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 23 June 2021

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.

Description

For patients successfully resuscitated who got restoration of spontaneous circulation (ROSC) after cardiopulmonary resuscitation (CPR), the course is usually marked by a post-resuscitation syndrome including multiple organ failures of various intensity and anoxic brain damage. The cardiocirculatory failure usually dominates the clinical picture, and it often leads to multiorgan failure. This hemodynamic failure is multifactorial, including at various levels vasoplegia, myocardial dysfunction, endotoxin release and adrenal dysfunction and is at least partly related to a hormonal defect that could be counteracted by hormonal supplementation. Such a substitutive opotherapy by hydrocortisone and AVP could improve hemodynamic failure and decrease overall mortality in this setting.

This trial is a superiority multicentric trial and patients will be randomized in a 1:1:1:1 ratio using an electronic CRF.

Investigational medicinal products:

  • Arginin-vasopressin or AVP (REVERPLEG) The solution for infusion is prepared by diluting 40 I.U. REVERPLEG with sodium chloride 9 mg/ml (0.9%) solution. The total volume after dilution should be 50 ml (equivalent to 0.8 I.U. AVP per ml).

AVP will be administered according to mean arterial pressure to target a 65mmHg blood pressure for max 3 days.

  • HYDROCORTISONE HEMISUCCINATE Vials with lyophilisate (100mg hydrocortisone) are provided by SERB laboratory. Hydrocortisone hemisuccinate will be administered as a 50mg intravenous bolus every 6 hours after an initial dose of 100mg, for 7 consecutive days. Stop of treatment by hydrocortisone will be performed without tapering.

Comparator treatment: placebos.

17 ICU centers in France will participate to this study targetting 380 patient's enrollment in the study.

Details
Condition Postresuscitation Syndrome
Treatment Administration of AVP, Administration of placebo AVP, Administration of placebo hydrocortisone, Administration of hydrocortisone
Clinical Study IdentifierNCT04591990
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on23 June 2021

Eligibility

Yes No Not Sure

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 0.2g/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
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