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Vitamin
Hydroxocobalamin for Septic shock
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
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 moreSide effects data
From 2024 Phase 4 trial • 19 Patients • NCT0405499911%
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
3,324 Previous Clinical Trials
3,059,397 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
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