An observational study in Vasoplegia, Hemodynamics and Intensive Care Unit, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Centre Hospitalier Universitaire, Amiens · Observational
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.
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.
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's enrollment of 18 is below the median of 200 across 19 observational studies indexed under Vasoplegia.
Browse Vasoplegia studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.
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All SVR (systemic vascular resistance) patients over 18 years of age who had received a dose of HCB since January 1 2019 will be included. Patients who received treatment for another indication were not included.
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Exclusion Criteria:
A patient will be defined as a responder to hydroxocobolamin 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.
A patient will be defined as a non-responder to hydroxocobolamin infusion if there is not 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.
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.
Time frame: 1 hour
The change in average blood pressure over time in responder patients
Blood pressure is measured in units of millimeters of mercury (mmHg).
Time frame: one hour
The change in average blood pressure over time in non-responder patients
Blood pressure is measured in units of millimeters of mercury (mmHg).
Time frame: one hour
The change in doses of NAd (mg/h) in responder patients
Time frame: one hour
The change in doses of NAd (mg/h) in non-responder patients
Time frame: one hour
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Jan 2021, 11 months.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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