Vitamin B12a Vasoplegic Syndrome

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Vasoplegic Syndrome

In brief

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

Key facts

Study ID

NCT03735316

Run by

Mayo Clinic

People needed

8

Starts

2019-04-25

Expected to finish

2022-04-01

Last updated by the study team

2023-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Saint Mary's Hospital — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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