Vitamin B12a Vasoplegic Syndrome

Vasoplegic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03735316
• Other study ID #: 17-011130
• Status: Terminated
• Phase: Phase 2
• Start date: April 25, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Vasoplegia
• Vasoplegic Syndrome

Intervention

Drug:
• Hydroxocobalamin
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.

Procedure:
• Cardiopulmonary Bypass
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.

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

Locations

Country	Name	City	State
United States	Mayo Clinic Saint Mary's Hospital	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Arterial Pressure	The average pressure in a patient's arteries during one cardiac cycle	baseline, 4 hours
Secondary	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
Secondary	Change in Systolic Blood Pressure	The maximum arterial pressure during contraction of the left ventricle of the heart.	baseline, 4 hours
Secondary	Death	Number subject deaths	30 days
Secondary	Duration of Hospital Stay	Number of days subjects are hospitalized	30 days
Secondary	Duration of Intensive Care Stay	Number of days subjects are in the intensive care unit	30 days

External Links

•   Mayo Clinic Clinical Trials