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Vitamin B12a Vasoplegic Syndrome

Phase 2
Terminated
Conditions
Vasoplegic Syndrome
Interventions
Drug: Hydroxocobalamin
Drug: Placebos
Procedure: Cardiopulmonary Bypass
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
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.
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebosSubjects will receive placebo
B12aCardiopulmonary BypassSubjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV
PlaceboCardiopulmonary BypassSubjects will receive placebo
B12aHydroxocobalaminSubjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Primary Outcome Measures
NameTimeMethod
Change in Mean Arterial Pressurebaseline, 4 hours

The average pressure in a patient's arteries during one cardiac cycle

Secondary Outcome Measures
NameTimeMethod
Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocolbaseline, 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 Pressurebaseline, 4 hours

The maximum arterial pressure during contraction of the left ventricle of the heart.

Death30 days

Number subject deaths

Duration of Hospital Stay30 days

Number of days subjects are hospitalized

Duration of Intensive Care Stay30 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

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