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Vitamin

Vitamin B12a Vasoplegic Syndrome

Phase 2
Waitlist Available
Led By James A. Nelson, M.B.B.S.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is testing Hydroxocobalamin, a form of vitamin B12, to help patients with low blood pressure after heart surgery. The medication works by improving blood flow and red blood cell production to raise blood pressure.

Eligible Conditions
  • Septic shock

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Mean Arterial Pressure
Secondary study objectives
Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol
Change in Systolic Blood Pressure
Death
+2 more

Side effects data

From 2024 Phase 4 trial • 19 Patients • NCT04054999
11%
Surgical and medical procedures - Other.
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cyanokit
Methylene Blue

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: B12aExperimental Treatment2 Interventions
Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Group II: PlaceboPlacebo Group2 Interventions
Subjects will receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxocobalamin
FDA approved

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,061,015 Total Patients Enrolled
James A. Nelson, M.B.B.S.Principal Investigator - Mayo Clinic
Mayo Clinic Health System-Mankato, St. James Medical Center-Mayo Health System
~1 spots leftby Dec 2025
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