RecruitingPhase 3NCT04591990

HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

HYdrocortisone and VAsopressin in Post-REsuscitation Syndrome


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

380 participants

Start Date

May 27, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This French ICU study is testing whether a combination of arginine-vasopressin (AVP) and hydrocortisone — two hormones that can support blood pressure and organ function — works better than the current standard treatment (norepinephrine alone) in patients who survive a cardiac arrest but then develop dangerous low blood pressure. The study is comparing survival and brain recovery at 30 days between patients given the hormone combination versus a placebo added to standard care. Eligible adults (18+) must have had a cardiac arrest with sustained return of spontaneous circulation, developed shock within 24 hours requiring high-dose vasopressors, and be enrolled within 9 hours of starting those medications — people with known adrenal insufficiency, ongoing steroid use, or gastrointestinal bleeding are not eligible. Participation involves IV infusions of the study drugs or placebo in an ICU setting for up to 7 days, with close monitoring. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdministration of AVP

Administration of AVP

DRUGAdministration of placebo AVP

Administration of placebo AVP

DRUGAdministration of placebo hydrocortisone

Administration of placebo hydrocortisone

DRUGAdministration of hydrocortisone

Administration of hydrocortisone


Locations(14)

Intensive care unit, CHU Amiens- Picardie

Amiens, France

Intensive care unit, CHU Angers

Angers, France

Intensive care unit, CHI Robert Ballanger

Aulnay-sous-Bois, France

Medical Intensive Care Unit, Ambroise Paré hospital, APHP

Boulogne-Billancourt, France

Intensive care unit, CH public du Cotentin

Cherbourg, France

Intensive care unit, CHU Dijon

Dijon, France

Intensive care unit, Hospices civils de Lyon

Lyon, France

Intensive care unit, Hôpital Jacques Cartier

Massy, France

Intensive care unit, CHU Montpellier

Montpellier, France

Intensive care unit, Brabois hospital

Nancy, France

Intensive care unit, Hotel Dieu hospital

Nantes, France

Intensive care unit, Clinique Ambroise Paré

Neuilly-sur-Seine, France

Intensive care unit, Cochin hospital, APHP

Paris, France

Intensive care unit, André Mignot hospital

Versailles, France

View Full Details on ClinicalTrials.gov

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NCT04591990