Vitamin B12a Vasoplegic Syndrome
- Conditions
- Vasoplegic Syndrome
- Interventions
- Registration Number
- NCT03735316
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The study team will evaluate the medication Hydroxocobalamin (B12a) for treatment of low blood pressure after cardiac surgery.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebos Subjects will receive placebo B12a Cardiopulmonary Bypass Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV Placebo Cardiopulmonary Bypass Subjects will receive placebo B12a Hydroxocobalamin Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV
- Primary Outcome Measures
Name Time Method Change in Mean Arterial Pressure baseline, 4 hours The average pressure in a patient's arteries during one cardiac cycle
- Secondary Outcome Measures
Name Time Method Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol baseline, 4 hours Vasopressors are administered and adjusted to maintain blood pressure. The combined dose of vasopressor dosage was calculated as norepinepheine equivalents listed in Table 1 of the protocol appendix and measured as a secondary outcome through the first 4 hours after intevention.
Change in Systolic Blood Pressure baseline, 4 hours The maximum arterial pressure during contraction of the left ventricle of the heart.
Death 30 days Number subject deaths
Duration of Hospital Stay 30 days Number of days subjects are hospitalized
Duration of Intensive Care Stay 30 days Number of days subjects are in the intensive care unit
Trial Locations
- Locations (1)
Mayo Clinic Saint Mary's Hospital
🇺🇸Rochester, Minnesota, United States