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New treatment option for Postresuscitation Syndrome
Official title HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome
ClinicalTrials.gov ID: NCT04591990
What this study is testing
What is Administration of AVP?
Administration of AVP is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for postresuscitation syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- 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.
You likely can't join if
- 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
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...
- 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Aulnay-sous-Bois, France
- Boulogne-Billancourt, France
- Cherbourg, France
- Dijon, France
- Lyon, France
- Massy, France
- Montpellier, France
- Nancy, France
- Nantes, France
- Neuilly-sur-Seine, France
- Paris, France
- Versailles, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Aulnay-sous-Bois, France; Boulogne-Billancourt, France; Cherbourg, France; Dijon, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.