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Vitamin B12a Vasoplegic Syndrome

Primary Purpose

Vasoplegic Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxocobalamin
Cardiopulmonary Bypass
Placebos
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vasoplegic Syndrome focused on measuring Vitamin B12a, Hypotension, Cardiopulmonary Bypass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic Saint Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

B12a

Placebo

Arm Description

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

Subjects will receive placebo

Outcomes

Primary Outcome Measures

Change in Mean Arterial Pressure
The average pressure in a patient's arteries during one cardiac cycle

Secondary Outcome Measures

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.
Change in Systolic Blood Pressure
The maximum arterial pressure during contraction of the left ventricle of the heart.
Death
Number subject deaths
Duration of Hospital Stay
Number of days subjects are hospitalized
Duration of Intensive Care Stay
Number of days subjects are in the intensive care unit

Full Information

First Posted
November 7, 2018
Last Updated
May 6, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03735316
Brief Title
Vitamin B12a Vasoplegic Syndrome
Official Title
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study for High-Dose Hydroxocobalamin (Vitamin B12A) for Vasopressor Refractory Hypotension Following Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment over study period
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasoplegic Syndrome
Keywords
Vitamin B12a, Hypotension, Cardiopulmonary Bypass

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B12a
Arm Type
Experimental
Arm Description
Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo
Intervention Type
Drug
Intervention Name(s)
Hydroxocobalamin
Other Intervention Name(s)
Cyanokit®, Vitamin B12a
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cardiopulmonary Bypass
Other Intervention Name(s)
CPB
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
Primary Outcome Measure Information:
Title
Change in Mean Arterial Pressure
Description
The average pressure in a patient's arteries during one cardiac cycle
Time Frame
baseline, 4 hours
Secondary Outcome Measure Information:
Title
Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol
Description
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
Title
Change in Systolic Blood Pressure
Description
The maximum arterial pressure during contraction of the left ventricle of the heart.
Time Frame
baseline, 4 hours
Title
Death
Description
Number subject deaths
Time Frame
30 days
Title
Duration of Hospital Stay
Description
Number of days subjects are hospitalized
Time Frame
30 days
Title
Duration of Intensive Care Stay
Description
Number of days subjects are in the intensive care unit
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A. Nelson, M.B.B.S.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Saint Mary's Hospital
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Vitamin B12a Vasoplegic Syndrome

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