Vitamin B12a Vasoplegic Syndrome

Sponsor

Mayo Clinic (Other)

Overall Status

Terminated

CT.gov ID

NCT03735316

Collaborator

(none)

Enrollment

Location

Arms

35.2

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vasoplegic Syndrome	Drug: Hydroxocobalamin Procedure: Cardiopulmonary Bypass Drug: Placebos	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Masking and blinding will be carried out by the research pharmacy with unmasking to be performed at study completion through the research pharmacy and statistician.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 25, 2019

Actual Primary Completion Date :

Apr 1, 2022

Actual Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: B12a Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV	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. Other Names: Cyanokit®, Vitamin B12a 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. Other Names: CPB
Placebo Comparator: Placebo Subjects will receive placebo	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. Other Names: CPB Drug: Placebos Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.

Arm

Intervention/Treatment

Experimental: B12a

Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV

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.

Other Names:

Cyanokit®, Vitamin B12a

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.

Other Names:

CPB

Placebo Comparator: Placebo

Subjects will receive placebo

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.

Other Names:

CPB

Drug: Placebos

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

Outcome Measures

Primary Outcome Measures

Change in Mean Arterial Pressure [baseline, 4 hours]
The average pressure in a patient's arteries during one cardiac cycle

Secondary Outcome Measures

Change in Vasopressor infusion rates [baseline, 4 hours]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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