Vitamin B12a Vasoplegic Syndrome

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Hydroxocobalamin; Vitamin B 12; Vitamin B Complex; Vitamins

Criteria

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