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Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock

Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04964492
Acronym
VASOKIT
Enrollment
18
Registered
2021-07-16
Start date
2020-01-15
Completion date
2021-01-08
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamics, Intensive Care Unit, Shock, Vasoplegia

Keywords

vasoplegia, hydroxocobalamin, hemodynamics, intensive care unit, shock

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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of patients responding to treatment with HCB1 hourA 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

MeasureTime frameDescription
The change in average blood pressure over time in responder patientsone hourBlood pressure is measured in units of millimeters of mercury (mmHg).
The change in average blood pressure over time in non-responder patientsone hourBlood pressure is measured in units of millimeters of mercury (mmHg).
The change in doses of NAd (mg/h) in responder patientsone hour
The change in doses of NAd (mg/h) in non-responder patientsone hour

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026