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Phase 3
Age: 18Years +
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ID04591990

Study of Hydrocortisone and Arginine-Vasopressin to Improve Survival and Brain Recovery After Cardiac Arrest with Shock

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

380

Participants Needed

14

Research Sites

N/A

Total Duration

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

Research Team

G

Guillaume GERI, MD, PhD

A

Alain Cariou, MD, PhD

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