HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome
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- STATUS
- Recruiting
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- End date
- May 23, 2023
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- participants needed
- 380
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- sponsor
- Assistance Publique - Hôpitaux de Paris
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.
Description
For patients successfully resuscitated who got restoration of spontaneous circulation (ROSC) after cardiopulmonary resuscitation (CPR), the course is usually marked by a post-resuscitation syndrome including multiple organ failures of various intensity and anoxic brain damage. The cardiocirculatory failure usually dominates the clinical picture, and it often leads to multiorgan failure. This hemodynamic failure is multifactorial, including at various levels vasoplegia, myocardial dysfunction, endotoxin release and adrenal dysfunction and is at least partly related to a hormonal defect that could be counteracted by hormonal supplementation. Such a substitutive opotherapy by hydrocortisone and AVP could improve hemodynamic failure and decrease overall mortality in this setting.
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.
Details
| Condition | Postresuscitation Syndrome |
|---|---|
| Treatment | Administration of AVP, Administration of placebo AVP, Administration of placebo hydrocortisone, Administration of hydrocortisone |
| Clinical Study Identifier | NCT04591990 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Last Modified on | 23 June 2021 |
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