Vitamin B12a Vasoplegic Syndrome

Phase 2TerminatedNCT03735316

Mayo Clinic8 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Vasoplegic Syndrome

Interventions

HydroxocobalaminDRUG

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.

Cardiopulmonary BypassPROCEDURE

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.

PlacebosDRUG

Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic Saint Mary's Hospital

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in Mean Arterial Pressure

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

Time frame: baseline, 4 hours

Secondary Outcomes

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.

Time frame: baseline, 4 hours

Change in Systolic Blood Pressure

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

Time frame: baseline, 4 hours

Death

Number subject deaths

Time frame: 30 days

Duration of Hospital Stay

Number of days subjects are hospitalized

Time frame: 30 days

Duration of Intensive Care Stay

Number of days subjects are in the intensive care unit

Time frame: 30 days

Data from ClinicalTrials.gov

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