Vitamin B12a Vasoplegic Syndrome

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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