Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock

Recruiting

• Conditions: Vasoplegia; Intensive Care Unit; Shock; Hemodynamics

• Registration Number: NCT04964492
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

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.

Study Timeline

• Study Start: 2021-07-13
• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-16
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients responding to treatment with HCB	1 hour	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.

Secondary Outcome Measures

Name	Time	Method
The change in average blood pressure over time in responder patients	one hour	Blood pressure is measured in units of millimeters of mercury (mmHg).
The change in average blood pressure over time in non-responder patients	one hour	Blood pressure is measured in units of millimeters of mercury (mmHg).
The change in doses of NAd (mg/h) in responder patients	one hour
The change in doses of NAd (mg/h) in non-responder patients	one hour

Trial Locations

Locations (1)

CHU Amiens-Picardie; 🇫🇷 Amiens, France