Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT04778605
Status:
UNKNOWN
Last Update Posted:
2021-03-03
First Post:
2021-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
MYTHICCS
Brief Summary:
Compare the microcirculatory reactivity before and after a 30-minute intravenous infusion of 40 mg/kg vitamin C and evaluate intra-individual variation of hemodynamic parameters between T0 and T1.
Detailed Description:
This is a transversal study allowing to compare the microcirculatory reactivity before and after a 30-minute intravenous infusion of 40 mg/kg vitamin C.
Design:
• A monocentric, open-label, transversal study
Sample size :
30 patients
Assessement:
Between 6 hours and 24 hours after admission, the patient will be included after collection of the non opposition.
There will be two evaluation times: T0 before the start of vitamin C's perfusion, and T1: 1 hour after the end.
No interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of data base.
Design:
• A monocentric, open-label, transversal study
Sample size :
30 patients
Assessement:
Between 6 hours and 24 hours after admission, the patient will be included after collection of the non opposition.
There will be two evaluation times: T0 before the start of vitamin C's perfusion, and T1: 1 hour after the end.
No interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of data base.
Study Oversight
Has Oversight DMC:
False
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?: