Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock

Shock Clinical Trial

— VASOKIT  

Official title:

Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04964492
• Other study ID #: PI2020_843_0124
• Status: Recruiting
• Start date: July 13, 2021
• Est. completion date: October 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Pierre HUETTE, MD
• Phone: 03 22 08 78 99
• Email: huette.pierre[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All SVR patients over 18 years of age who had received a dose of HCB since January 1 2019 will be included.

Exclusion Criteria:

• Patients who received treatment for another indication were not included.

Related Conditions & MeSH terms

• Hemodynamics
• Intensive Care Unit
• Shock
• Vasoplegia

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients responding to treatment with HCB	A patient will be defined as a responder to hydroxocobalamin infusion if there is an increase of more than 20% in average blood pressure, relative to the pre-treatment value, for at least 15 minutes within one hour of treatment administration.	1 hour
Secondary	The change in average blood pressure over time in responder patients	Blood pressure is measured in units of millimeters of mercury (mmHg).	one hour
Secondary	The change in average blood pressure over time in non-responder patients	Blood pressure is measured in units of millimeters of mercury (mmHg).	one hour
Secondary	The change in doses of NAd (mg/h) in responder patients		one hour
Secondary	The change in doses of NAd (mg/h) in non-responder patients		one hour