Clinical trial NCT04964492: Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock
Official title: Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vasoplegia
Hemodynamics
Intensive Care Unit
Shock
Keywords: vasoplegia
hydroxocobalamin
hemodynamics
intensive care unit
shock
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients responding to treatment with HCB
timeFrame: 1 hour
Secondary outcomes:
measure: The change in average blood pressure over time in responder patients
timeFrame: one hour
measure: The change in average blood pressure over time in non-responder patients
timeFrame: one hour
measure: The change in doses of NAd (mg/h) in responder patients
timeFrame: one hour
measure: The change in doses of NAd (mg/h) in non-responder patients
timeFrame: one hour
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References: