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Vitamin B12 for Septic Shock (B12 Trial)

Phase 2
Waitlist Available
Led By Jayshil J Patel, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of septic shock, as defined by sepsis-3 criteria
Be older than 18 years old
Must not have
History of calcium oxaluria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 24, and 48 hours

Summary

This trial is testing if a high dose of vitamin B12 given through an injection can help septic shock patients by reducing harmful substances in their blood and stabilizing their blood pressure.

Who is the study for?
This trial is for adults over 18 with septic shock, admitted to the MICU at Froedtert Hospital and meeting sepsis-3 criteria. It's not for those with a history of calcium oxaluria.
What is being tested?
The study tests if a single dose of IV vitamin B12 (5 grams) can be feasibly administered alongside standard care in septic shock patients, compared to a placebo group.
What are the potential side effects?
Potential side effects from high-dose vitamin B12 may include skin reactions, diarrhea, blood clots or allergic reactions; however, specific risks will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with septic shock according to sepsis-3 criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had calcium oxalate kidney stones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 24, and 48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 24, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of completing clinical and laboratory protocols
Secondary study objectives
Change in vasopressor dose
Hydrogen Sulfide Concentration
Mortality
+1 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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HydroxocobalaminExperimental Treatment1 Intervention
Single IV infusion administered over a 10-15 minute period
Group II: Saline PlaceboPlacebo Group1 Intervention
Single IV saline administered over a 10-15 minute period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxocobalamin
2019
Completed Phase 4
~90

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,181,682 Total Patients Enrolled
1 Trials studying Sepsis
20 Patients Enrolled for Sepsis
Jayshil J Patel, MDPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

Hydroxocobalamin Clinical Trial Eligibility Overview. Trial Name: NCT03783091 — Phase 2
Sepsis Research Study Groups: Saline Placebo, Hydroxocobalamin
Sepsis Clinical Trial 2023: Hydroxocobalamin Highlights & Side Effects. Trial Name: NCT03783091 — Phase 2
Hydroxocobalamin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03783091 — Phase 2
~3 spots leftby Dec 2025
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