HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome (NCT04591990) | Clinical Trial Compass
RecruitingPhase 3
HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome
France380 participantsStarted 2021-05-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a combination of hydrocortisone and vasopressin for post-resuscitation syndrome — can you explain what each of those drugs does in this context and why using them together might help compared to standard care after a cardiac arrest?
2Since this is a Phase 3 trial, there's already some earlier-phase evidence behind it — what does the existing safety and effectiveness data look like, and are there any known risks I should be aware of before considering something like this?
3The trial's main goal is measuring neurological outcome — what does that actually mean in practical terms, and how would my own neurological recovery be tracked and evaluated if I were part of this study?
4Given that post-resuscitation syndrome can be a critical, fast-moving condition, how quickly would a decision about enrolling in this trial need to be made, and would I or my family have enough time to fully understand what we're agreeing to?
5Is there a standard treatment approach for post-resuscitation syndrome that you'd recommend for my situation, and how does what this trial is testing compare to what I'd receive outside of the study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.