HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome
NCT ID: NCT04591990
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
380 participants
INTERVENTIONAL
2021-05-27
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vasopressin, Epinephrine, and Steroids for Cardiac Arrest
NCT00729794
Combined Vasopressin, Methylprednisolone, and Epinephrine for Inhospital Cardiac Arrest
NCT00411879
Effect of Vasopressin, Steroid, and Epinephrine Treatment in Patients With Out-of-hospital Cardiac Arrest
NCT03317197
Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest
NCT00127907
Registry of Patients in Shock Treated With Vasopressin
NCT06422975
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This trial is a superiority multicentric trial and patients will be randomized in a 1:1:1:1 ratio using an electronic CRF.
Investigational medicinal products:
\- Arginin-vasopressin or AVP (REVERPLEG) The solution for infusion is prepared by diluting 40 I.U. REVERPLEG® with sodium chloride 9 mg/ml (0.9%) solution. The total volume after dilution should be 50 ml (equivalent to 0.8 I.U. AVP per ml).
AVP will be administered according to mean arterial pressure to target a 65mmHg blood pressure for max 3 days.
\- HYDROCORTISONE HEMISUCCINATE Vials with lyophilisate (100mg hydrocortisone) are provided by SERB laboratory. Hydrocortisone hemisuccinate will be administered as a 50mg intravenous bolus every 6 hours after an initial dose of 100mg, for 7 consecutive days. Stop of treatment by hydrocortisone will be performed without tapering.
Comparator treatment: placebos.
17 ICU centers in France will participate to this study targetting 380 patient's enrollment in the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AVP + placebo hydrocortisone
REVERPLEG® 40 IU/2mL+ Placebo of hydrocortisone.
Administration of AVP
Administration of AVP
Administration of placebo hydrocortisone
Administration of placebo hydrocortisone
placebo AVP + hydrocortisone
Placebo of REVERPLEG® 40 IU/2mL + Hydrocortisone 100mg UPJOHN®.
Administration of placebo AVP
Administration of placebo AVP
Administration of hydrocortisone
Administration of hydrocortisone
AVP + hydrocortisone
REVERPLEG® 40 IU/2mL + Hydrocortisone 100mg UPJOHN®.
Administration of AVP
Administration of AVP
Administration of hydrocortisone
Administration of hydrocortisone
placebo AVP + placebo hydrocortisone
Placebo of REVERPLEG® 40 IU/2mL + placebo of hydrocortisone
Administration of placebo AVP
Administration of placebo AVP
Administration of placebo hydrocortisone
Administration of placebo hydrocortisone
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Administration of AVP
Administration of AVP
Administration of placebo AVP
Administration of placebo AVP
Administration of placebo hydrocortisone
Administration of placebo hydrocortisone
Administration of hydrocortisone
Administration of hydrocortisone
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guillaume GERI, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Intensive Care Unit, Clinique Ambroise Paré, 92200 Neuilly sur seine
Alain CARIOU, MD, PhD
Role: STUDY_DIRECTOR
Medical Intensive Care Unit, Cochin Hospital, APHP, 75014 Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Witten L, Gardner R, Holmberg MJ, Wiberg S, Moskowitz A, Mehta S, Grossestreuer AV, Yankama T, Donnino MW, Berg KM. Reasons for death in patients successfully resuscitated from out-of-hospital and in-hospital cardiac arrest. Resuscitation. 2019 Mar;136:93-99. doi: 10.1016/j.resuscitation.2019.01.031. Epub 2019 Jan 30.
Geri G, Lascarrou JB, Levy B, Asfar P, Muller G, Legriel S, Ricome S, Cour M, Klouche K, Sauneuf B, Quenot JP, Bougouin W, Cariou A; HYVAPRESS investigators. Hydrocortisone and arginine vasopressin in post-resuscitation shock: the HYVAPRESS trial. Resusc Plus. 2025 May 19;24:100982. doi: 10.1016/j.resplu.2025.100982. eCollection 2025 Jul.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-001620-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
APHP200033
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.