Vasoplegic SyndromePhase 2NCT03735316

Vitamin B12a Vasoplegic Syndrome

A Phase 2 study testing Hydroxocobalamin and Cardiopulmonary Bypass in people with Vasoplegic Syndrome, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The study team will evaluate the medication Hydroxocobalamin (B12a) for treatment of low blood pressure after cardiac surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vasoplegic Syndrome
What is being tested?: Hydroxocobalamin and Cardiopulmonary Bypass
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 25 Apr 2019to 1 Apr 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Any patient for whom we are able to obtain consent ahead of their procedure
Patients presenting for a procedure in which cardiopulmonary bypass will be required
Considered high risk for vasoplegic syndrome
Has no contraindications to arterial line or PA catheter placement
Develops high-dose vasopressors for 30 min or longer and refractory hypotension consistent with vasoplegic syndrome within 24 hours of coming off cardiopulmonary bypass.

Who cannot join

Age<18 years
Known pregnancy or patients without a documented pregnancy test if not menopausal.
Known prior anaphylactic or allergic reaction to B12a
CKD stage 4 or worse
ECMO (extracorporeal membrane oxygenation) prior to study consent.
Patients currently on cardiopulmonary bypass

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic Saint Mary's Hospital
Rochester, Minnesota, 55902

Other trials in United States

About this study

Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study for High-Dose Hydroxocobalamin (Vitamin B12A) for Vasopressor Refractory Hypotension Following Cardiopulmonary Bypass

The study team will evaluate the medication Hydroxocobalamin (B12a) for treatment of low blood pressure after cardiac surgery.

Read the detailed description

If subjects meet the criteria for inclusion in the study based on the subjects blood pressure the subject will be randomized to receive the study drug or a placebo. Subjects blood pressure will be monitored closely for the first 30 minutes and then have standard intensive care unit (ICU) care afterwards. Kidney dysfunction will be assessed for changes in urine production and laboratory values that are followed as a part of standard postoperative care. Study coordinators will obtain these values from subjects medical records for 7 days and subjects will be contacted by phone for follow up after 30 days.

Conditions: Vasoplegic Syndrome
Being tested: Hydroxocobalamin, Cardiopulmonary Bypass, Placebos
Keywords: Vitamin B12a, Hypotension, Cardiopulmonary Bypass
Medical subject headings: Vasoplegia, Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HydroxocobalaminDrug
Also called Cyanokit®, Vitamin B12a
5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.
Cardiopulmonary BypassProcedure or surgery
Also called CPB
Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
PlacebosDrug
Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.

Study groups in NCT03735316
Study group	Role	What they receive
B12a	Experimental	Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV Receives: Drug: Hydroxocobalamin; Procedure: Cardiopulmonary Bypass
Placebo	Placebo comparator	Subjects will receive placebo Receives: Procedure: Cardiopulmonary Bypass; Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean Arterial Pressure
The average pressure in a patient's arteries during one cardiac cycle
Measured: baseline, 4 hours

Secondary outcomes (5)

Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol
Vasopressors are administered and adjusted to maintain blood pressure. The combined dose of vasopressor dosage was calculated as norepinepheine equivalents listed in Table 1 of the protocol appendix and measured as a secondary outcome through the first 4 hours after intevention.
Measured: baseline, 4 hours
Change in Systolic Blood Pressure
The maximum arterial pressure during contraction of the left ventricle of the heart.
Measured: baseline, 4 hours
Death
Number subject deaths
Measured: 30 days
Duration of Hospital Stay
Number of days subjects are hospitalized
Measured: 30 days
Duration of Intensive Care Stay
Number of days subjects are in the intensive care unit
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 20191 Apr 2022

First posted8 Nov 2018
Study start25 Apr 2019
Primary completion1 Apr 2022
Study completion1 Apr 2022

Why it stopped: Insufficient recruitment over study period

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vasoplegic SyndromeStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe 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: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03735316
Sponsor's protocol ID: 17-011130
Status last verified: May 2023
First submitted: 7 Nov 2018
Last updated: 10 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Septic Shock, Acute Respiratory Distress Syndrome
RecruitingObservational study
Angiotensin II Stress Test. Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II.
Shock, Vasoplegic Syndrome
Active, not recruitingObservational study
Vasoplegic Syndrome in Cardiac Surgery
Vasoplegic Syndrome of Cardiac Surgery
RecruitingObservational study
Evaluation of the HPA Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery
Vasoplegic Syndrome in Adult Cardiac Surgery
RecruitingObservational study
Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock
Cardiogenic Shock Acute, Bypass, Cardiopulmonary

All Vasoplegic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study for High-Dose Hydroxocobalamin (Vitamin B12A) for Vasopressor Refractory Hypotension Following Cardiopulmonary Bypass
ClinicalTrials.gov ID: NCT03735316
Acronym / sponsor ID: 17-011130
Conditions: Vasoplegic Syndrome
Keywords: Vitamin B12a, Hypotension, Cardiopulmonary Bypass
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient recruitment over study period
Enrolment: 8 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 25 Apr 2019 (actual)
Primary completion: 1 Apr 2022 (actual)
Study completion: 1 Apr 2022 (actual)
First posted: 8 Nov 2018 (actual)
Results: Posted 10 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study team will evaluate the medication Hydroxocobalamin (B12a) for treatment of low blood pressure after cardiac surgery.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
B12a	Experimental	Drug: Hydroxocobalamin, Procedure: Cardiopulmonary BypassSubjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Placebo	Placebo comparator	Procedure: Cardiopulmonary Bypass, Drug: PlacebosSubjects will receive placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Any patient for whom we are able to obtain consent ahead of their procedure
Patients presenting for a procedure in which cardiopulmonary bypass will be required
Considered high risk for vasoplegic syndrome
Has no contraindications to arterial line or PA catheter placement
Develops high-dose vasopressors for 30 min or longer and refractory hypotension consistent with vasoplegic syndrome within 24 hours of coming off cardiopulmonary bypass.

Key exclusion criteria (6 listed)

Age<18 years
Known pregnancy or patients without a documented pregnancy test if not menopausal.
Known prior anaphylactic or allergic reaction to B12a
CKD stage 4 or worse
ECMO (extracorporeal membrane oxygenation) prior to study consent.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HydroxocobalaminAlso: Cyanokit®, Vitamin B12a5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.	Drug	B12a
Cardiopulmonary BypassAlso: CPBTechnique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.	Procedure or surgery	B12a, Placebo
PlacebosPlacebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.	Drug	Placebo

Primary outcome

Change in Mean Arterial Pressure
Time frame: baseline, 4 hours
The average pressure in a patient's arteries during one cardiac cycle

5 secondary outcomes

Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol
Time frame: baseline, 4 hours
Change in Systolic Blood Pressure
Time frame: baseline, 4 hours
Death
Time frame: 30 days
Duration of Hospital Stay
Time frame: 30 days
Duration of Intensive Care Stay
Time frame: 30 days

Results and safety

Results posted to the registry on 10 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
B12a	4	4
Placebo	4	4

Primary outcome: Change in Mean Arterial Pressure

Time frame: baseline, 4 hours. Median (Inter-Quartile Range). Unit: mmHg

Measure	B12a n = 4	Placebo n = 4
Value	6 (1.25 to 9.5)	-0.5 (-2.75 to 1.25)

Population analysed: Terminated study. Insufficient recruitment over study period

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from baseline to end of study, approximately 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
B12a	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Placebo	0 of 4 (0%)	2 of 4 (50%)	0 of 4

Limitations and caveats (from the sponsor): Terminated study. Insufficient recruitment over study period

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Vasoplegic Syndrome

RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingObservational study
Angiotensin II Stress Test. Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II.
Shock, Vasoplegic Syndrome
Active, not recruitingObservational study
Vasoplegic Syndrome in Cardiac Surgery
Vasoplegic Syndrome of Cardiac Surgery
RecruitingObservational study
Evaluation of the HPA Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery
Vasoplegic Syndrome in Adult Cardiac Surgery
RecruitingObservational study
Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock
Cardiogenic Shock Acute, Bypass, Cardiopulmonary

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.

James A. Nelson, M.B.B.S. principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hydroxocobalamin and Cardiopulmonary Bypass in people with Vasoplegic Syndrome, run by Mayo Clinic at 1 site in United States.

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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 May 2023. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Mean Arterial Pressure (time frame: baseline, 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03735316.

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 10 May 2023.