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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID04591990

HYdrocortisone and VAsopressin in Post-REsuscitation Syndrome

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-12

380

Participants Needed

14

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of arginine-vasopressin AVP and hydrocortisone compared with norepinephrine to improve survival and neurological recovery 30 days after cardiac arrest in patients experiencing hemodynamic failure. This phase 3, multicenter trial focuses on patients who have been successfully resuscitated but face post-resuscitation syndrome, which includes multiple organ failures and brain damage caused by a combination of heart and circulatory problems often linked to hormonal imbalances. The study randomly assigns participants to one of four groups AVP with placebo hydrocortisone, placebo AVP with hydrocortisone, both AVP and hydrocortisone, or placebo for both. AVP is given via infusion to maintain a target blood pressure for up to 3 days, while hydrocortisone is administered intravenously every 6 hours for 7 days without tapering at the end. Placebo treatments are used to compare effects. The trial involves 17 intensive care units in France and aims to enroll 380 patients. Participants will be closely monitored throughout the study with assessments including neurological outcome measured at day 30, along with various mortality causes and brain damage evaluations at 48 and 72 hours. Researchers will track survival, brain function recovery, and hemodynamic stability during and after treatment. The study uses quadruple masking to ensure unbiased results and includes ongoing safety and follow-up evaluations until December 2025.

CONDITIONS

Brief Title

HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients over 18 years old
  • Cardiac arrest with sustained return of spontaneous circulation lasting more than 30 minutes
  • Post-resuscitation shock with low blood pressure unresponsive to fluids, requiring norepinephrine or epinephrine infusion at 0.2 µg/kg/min or more for at least 3 hours
  • Randomization within 9 hours of starting norepinephrine infusion
  • Written informed consent from the patient or a legal representative
Not Eligible

You will not qualify if you...

  • Cardiac arrest caused by trauma or neurological reasons
  • Shock due to uncontrolled bleeding
  • Known adrenal insufficiency
  • Limitations on life-sustaining treatments
  • Current steroid treatment of any dose
  • Use of extracorporeal circulatory assistance
  • Gastrointestinal bleeding within the past 6 weeks
  • Pregnancy or breastfeeding
  • Participation in another interventional trial or within exclusion period after a previous trial
  • Allergy to arginine-vasopressin or hydrocortisone or their components
  • Legal protection status preventing consent
  • No affiliation with the French healthcare system

Research Team

G

Guillaume GERI, MD, PhD

A

Alain Cariou, MD, PhD

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