Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04591990
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2020-10-12
Brief Title:
HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
HYdrocortisone and VAsopressin in Post-REsuscitation Syndrome
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYVAPRESS
Brief 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
Detailed 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 1111 ratio using an electronic CRF
Investigational medicinal products
- Arginin-vasopressin or AVP REVERPLEG The solution for infusion is prepared by diluting 40 IU REVERPLEG with sodium chloride 9 mgml 09 solution The total volume after dilution should be 50 ml equivalent to 08 IU 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 patients enrollment in the study
This trial is a superiority multicentric trial and patients will be randomized in a 1111 ratio using an electronic CRF
Investigational medicinal products
- Arginin-vasopressin or AVP REVERPLEG The solution for infusion is prepared by diluting 40 IU REVERPLEG with sodium chloride 9 mgml 09 solution The total volume after dilution should be 50 ml equivalent to 08 IU 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 patients enrollment in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-001620-33 | EUDRACT_NUMBER | None | None |