Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-26 @ 5:51 PM
Study NCT ID:
NCT04964492
Status:
UNKNOWN
Last Update Posted:
2023-02-10
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock
Sponsor:
Centre Hospitalier Universitaire, Amiens
Organization:
Study Overview
Official Title:
Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock
Status:
UNKNOWN
Status Verified Date:
2023-02
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:
VASOKIT
Brief Summary:
Through clinical cases or retrospective work with small sample size, some authors have observed an improvement in hemodynamic parameters, with a reduction or even withdrawal of norepinephrine after administration of a single dose of hydroxocobolamin (HCB) in refractory vasoplegic shock (cardiac surgery, liver transplantation and septic shock).
HCB produces beneficial alterations in NO metabolism and may be suitable in vasoplegic syndrome. In addition, HCB seems to be involved in the elimination of hydrogen sulfide which also has an endogenous vasodilator function in the vascular endothelium. By these different actions it would cause vasoconstriction in vascular smooth muscle cells. Previous reports demonstrate that HCB was useful for refractory vasoplegic syndrome.
The investigators will conduct a retrospective data collection of patients who was given intravenous HCB for refractory vasoplegic shock since January 2019.
HCB produces beneficial alterations in NO metabolism and may be suitable in vasoplegic syndrome. In addition, HCB seems to be involved in the elimination of hydrogen sulfide which also has an endogenous vasodilator function in the vascular endothelium. By these different actions it would cause vasoconstriction in vascular smooth muscle cells. Previous reports demonstrate that HCB was useful for refractory vasoplegic syndrome.
The investigators will conduct a retrospective data collection of patients who was given intravenous HCB for refractory vasoplegic shock since January 2019.
Detailed Description:
Vasoplegic shock is defined by arterial hypotension, a high cardiac output with a normal or high cardiac index, collapsed systemic vascular resistance (SVR) and high dose of norepinephrine in the absence of hypovolaemia. The drop in secondary organ perfusion pressure ultimately leads to multiple organ failure and death.
Through clinical cases or retrospective work with small sample size, some authors have observed an improvement in hemodynamic parameters, with a reduction or even withdrawal of norepinephrine after administration of a single dose of hydroxocobolamin (HCB) in refractory vasoplegic shock (cardiac surgery, liver transplantation and septic shock).
HCB produces beneficial alterations in NO metabolism and may be suitable in vasoplegic syndrome. In addition, HCB seems to be involved in the elimination of hydrogen sulfide which also has an endogenous vasodilator function in the vascular endothelium. By these different actions it would cause vasoconstriction in vascular smooth muscle cells. Previous reports demonstrate that HCB was useful for refractory vasoplegic syndrome.
The investigators will conduct a retrospective data collection of patients who was given intravenous HCB for refractory vasoplegic shock since January 2019.
Through clinical cases or retrospective work with small sample size, some authors have observed an improvement in hemodynamic parameters, with a reduction or even withdrawal of norepinephrine after administration of a single dose of hydroxocobolamin (HCB) in refractory vasoplegic shock (cardiac surgery, liver transplantation and septic shock).
HCB produces beneficial alterations in NO metabolism and may be suitable in vasoplegic syndrome. In addition, HCB seems to be involved in the elimination of hydrogen sulfide which also has an endogenous vasodilator function in the vascular endothelium. By these different actions it would cause vasoconstriction in vascular smooth muscle cells. Previous reports demonstrate that HCB was useful for refractory vasoplegic syndrome.
The investigators will conduct a retrospective data collection of patients who was given intravenous HCB for refractory vasoplegic shock since January 2019.
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?: