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Hydrocorticose and vasopressin in post-resuscitation syndrome
EU CTIS ID: 2024-516373-77-00
What this study is testing
to demonstrate the superiority of AVP and hydrocortisone compared with placebo regarding day-30 survival and neurological recovery in post-cardiac arrest patients with hemodynamic failure.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 tartrate/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 a legally authorized close relative, or emergency procedure
You likely can't join if
- Evidence for a traumatic or a neurological cause of cardiac arrest
- inclusion in another randomized trial involving a drug that could interact with either interventional drug
- Hypersensitivity to argipressin 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
See the full eligibility 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 tartrate/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 a legally authorized close relative, or emergency procedure
- Evidence for a traumatic or a neurological cause of cardiac arrest
- inclusion in another randomized trial involving a drug that could interact with either interventional drug
- Hypersensitivity to argipressin 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
- In-ICU cardiac arrest
- Shock due to uncontrolled haemorrhage
- Previously known adrenal insufficiency
- Limitation of life-sustaining therapies
- Ongoing treatment by any steroids, at a daily dose greater or equal to 7.5mg/d equivalent prednisone for at least 3 weeks
- Ongoing extra-corporeal circulatory assistance
- Gastrointestinal bleeding in the past 6 weeks
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.