Vitamin B12a Vasoplegic Syndrome

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

Detailed Description
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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.

Official Title
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A Phase II, Randomized, Double-Blind, Placebo-Controlled Study for High-Dose Hydroxocobalamin (Vitamin B12A) for Vasopressor Refractory Hypotension Following Cardiopulmonary Bypass

Conditions
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Vasoplegic Syndrome

Intervention / Treatment
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* Drug: Hydroxocobalamin
* Procedure: Cardiopulmonary Bypass
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B12a<br>Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV | Drug: Hydroxocobalamin<br>* 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.<br>* Other names: Cyanokit®, Vitamin B12a;Procedure: Cardiopulmonary Bypass<br>* Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.<br>* Other names: CPB;|
| Placebo Comparator: Placebo<br>Subjects will receive placebo | Procedure: Cardiopulmonary Bypass<br>* Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.<br>* Other names: CPB;Drug: Placebos<br>* Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Arterial Pressure | The average pressure in a patient's arteries during one cardiac cycle | baseline, 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol | 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. | baseline, 4 hours | 
| Change in Systolic Blood Pressure | The maximum arterial pressure during contraction of the left ventricle of the heart. | baseline, 4 hours | 
| Death | Number subject deaths | 30 days | 
| Duration of Hospital Stay | Number of days subjects are hospitalized | 30 days | 
| Duration of Intensive Care Stay | Number of days subjects are in the intensive care unit | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin B12a, Hypotension, Cardiopulmonary Bypass