Phase 2
N=20
A Trial of Vitamin B12 in Septic Shock
Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT03783091 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Feasibility of Clinical and Protocol Completion — 10; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hydroxocobalamin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Clinical and Protocol Completion |
10; 10 | — |
| SECONDARY Hydrogen Sulfide Concentration |
-13; -3 | — |
| SECONDARY Persistent Organ Dysfunction Syndrome (PODS) |
5; 4 | — |
| SECONDARY Change in Vasopressor Dose |
-28; 10 | — |
| SECONDARY ICU Mortality |
3; 4 | — |
Summary
This study will randomize 20 septic shock patients to receive either a single 5 gram dose of IV vitamin B12 (Cyanokit® Meridian Medical Technologies, Columbia, MD) versus placebo in addition to standard of care to test the feasibility of completing clinical and laboratory protocols.
Eligibility Criteria
Inclusion Criteria
- Adult patients at least 18 years of age
- Admitted to the Medical Intensive Care Unit (MICU) service at Froedtert Hospital
- Diagnosis of septic shock, as defined by sepsis-3 criteria
Exclusion Criteria
- History of calcium oxaluria
Data sourced from ClinicalTrials.gov (NCT03783091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.