VasoplegiaVASOKITNCT04964492
Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock
An observational study of Vasoplegia and Hemodynamics, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasoplegia, Hemodynamics, Intensive Care Unit
- Type of treatment
- Injection or infusion
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2020to 8 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All SVR patients over 18 years of age who had received a dose of HCB since January 1 2019 will be included.
Who cannot join
- Patients who received treatment for another indication were not included.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vasoplegia, Hemodynamics, Intensive Care Unit, Shock
- Keywords
- vasoplegia, hydroxocobalamin, hemodynamics, intensive care unit, shock
- Medical subject headings
- Vasoplegia, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| responders to treatment | 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. | |
| non-responders to treatment | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (4)
The change in average blood pressure over time in responder patients
Blood pressure is measured in units of millimeters of mercury (mmHg).
Measured: 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).
Measured: one hour
The change in doses of NAd (mg/h) in responder patients
Measured: one hour
The change in doses of NAd (mg/h) in non-responder patients
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start15 Jan 2020
- Primary completion8 Jan 2021
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasoplegiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964492
- Sponsor's protocol ID
- PI2020_843_0124
- Acronym
- VASOKIT
- Status last verified
- Jun 2026
- First submitted
- 13 Jul 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock
- ClinicalTrials.gov ID
- NCT04964492
- Acronym / sponsor ID
- VASOKIT / PI2020_843_0124
- Conditions
- Vasoplegia, Hemodynamics, Intensive Care Unit, Shock
- Keywords
- vasoplegia, hydroxocobalamin, hemodynamics, intensive care unit, shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| responders to treatment | – | –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. |
| non-responders to treatment | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All SVR patients over 18 years of age who had received a dose of HCB since January 1 2019 will be included.
Key exclusion criteria (1 listed)
- Patients who received treatment for another indication were not included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients responding to treatment with HCB
Time frame: 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.
4 secondary outcomes
The change in average blood pressure over time in responder patients
Time frame: one hour
The change in average blood pressure over time in non-responder patients
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasoplegia and Hemodynamics, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients responding to treatment with HCB (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.