Vitamin B12a Vasoplegic Syndrome

Mayo Clinic

Status and phase

Terminated

Phase 2

Conditions

Vasoplegic Syndrome

Treatments

Drug: Placebos

Procedure: Cardiopulmonary Bypass

Drug: Hydroxocobalamin

Study type

Interventional

Funder types

Other

Identifiers

NCT03735316

17-011130

Details and patient eligibility

About

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

Full 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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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