Vitamin B12a Vasoplegic Syndrome

What Was Tested

This registered phase 2 trial tested Cyanocobalamin (Vitamin B12).

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

It had two arms (groups): B12a (experimental) and Placebo (placebo comparator).

Subjects will receive placebo.

The registry classes the interventions as drug and procedure.

More on the Plan

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.

Who Took Part

Enrollment: 8 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Any patient for whom the researchers 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.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: age\<18 years; known pregnancy or patients without a documented pregnancy test if not menopausal; known prior anaphylactic or allergic reaction to b12a.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2019-04-25 with completion listed for 2022-04-01.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Change in Mean Arterial Pressure (time frame: baseline, 4 hours).

It also tracked 5 secondary outcomes, for example Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol, Change in Systolic Blood Pressure, Duration of Hospital Stay and Duration of Intensive Care Stay.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 8 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.