Reasons for death in patients successfully resuscitated from out-of-hospital and in-hospital cardiac arrest.
Lise Witten, Ryan Gardner, Mathias J Holmberg...
https://pubmed.ncbi.nlm.nih.gov/30710595/Actively Recruiting
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-12
380
Participants Needed
14
Research Sites
N/A
Total Duration
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
HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome
G
Guillaume GERI, MD, PhD
A
Alain Cariou, MD, PhD
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Assistance Publique - Hôpitaux de Paris
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days for hydrocortisone treatment and up to 3 days for vasopressin treatment
Participants receive hydrocortisone and/or arginin-vasopressin or placebos to manage post-resuscitation syndrome after cardiac arrest.
Daily visits for up to 7 days
Duration - 30 days
Participants are monitored for neurological outcomes and mortality up to 30 days after treatment.
Visits at 48 hours, 72 hours, and day 30
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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Lise Witten, Ryan Gardner, Mathias J Holmberg...
https://pubmed.ncbi.nlm.nih.gov/30710595/Guillaume Geri, Jean-Baptiste Lascarrou, Bruno Levy...
https://pubmed.ncbi.nlm.nih.gov/40503090/Assistance Publique - Hôpitaux de Paris
Lead Sponsor