Using hydrocortisone and vasopressin to improve outcomes after cardiac arrest

HYdrocortisone and VAsopressin in Post-REsuscitation Syndrome

This study is testing if using hydrocortisone and vasopressin can help improve survival and brain recovery in adults who have had a cardiac arrest and are struggling with serious health issues afterward.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 14 sites (Amiens and 13 other locations)
• Trial ID: NCT04591990 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of arginine-vasopressin (AVP) and hydrocortisone compared to norepinephrine in improving survival and neurological recovery in patients who have experienced cardiac arrest and subsequent hemodynamic failure. The study will involve adult patients who have been successfully resuscitated and are experiencing post-resuscitation syndrome, characterized by multiple organ failures and hemodynamic instability. Participants will be randomly assigned to receive either AVP, hydrocortisone, a placebo for AVP, or a placebo for hydrocortisone, with the goal of assessing the impact on day-30 survival rates and neurological outcomes. The trial will be conducted in multiple intensive care units across various locations.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who have experienced cardiac arrest and have been resuscitated but are still in shock requiring vasopressor support.

Not a fit: Patients with traumatic or neurological causes of cardiac arrest, uncontrolled hemorrhage, or those with known adrenal insufficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly improve survival rates and neurological recovery for patients after cardiac arrest.

How similar studies have performed: Other studies have explored hormonal therapies in similar contexts, but this specific combination of AVP and hydrocortisone in post-resuscitation syndrome is relatively novel.

Eligibility criteria

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.

Where this trial is running

Amiens and 13 other locations

• Intensive care unit, CHU Amiens- Picardie — Amiens, France (Recruiting)
• Intensive care unit, CHU Angers — Angers, France (Recruiting)
• Intensive care unit, CHI Robert Ballanger — Aulnay-sous-Bois, France (Recruiting)
• Medical Intensive Care Unit, Ambroise Paré hospital, APHP — Boulogne-Billancourt, France (Withdrawn)
• Intensive care unit, CH public du Cotentin — Cherbourg, France (Recruiting)
• Intensive care unit, CHU Dijon — Dijon, France (Recruiting)
• Intensive care unit, Hospices civils de Lyon — Lyon, France (Recruiting)
• Intensive care unit, Hôpital Jacques Cartier — Massy, France (Recruiting)
• Intensive care unit, CHU Montpellier — Montpellier, France (Recruiting)
• Intensive care unit, Brabois hospital — Nancy, France (Recruiting)
• Intensive care unit, Hotel Dieu hospital — Nantes, France (Recruiting)
• Intensive care unit, Clinique Ambroise Paré — Neuilly-sur-Seine, France (Recruiting)
• Intensive care unit, Cochin hospital, APHP — Paris, France (Recruiting)
• Intensive care unit, André Mignot hospital — Versailles, France (Recruiting)

Study contacts

• Principal investigator: Guillaume GERI, MD, PhD — Intensive Care Unit, Clinique Ambroise Paré, 92200 Neuilly sur seine
• Study coordinator: Guillaume GERI, MD, PhD

Conditions Postresuscitation Syndrome; intensive care; hydrocortisone; vasopressin; post-resuscitation syndrome