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Phase 2 Completed N=20 Randomized Quadruple-blind Treatment

A Trial of Vitamin B12 in Septic Shock

Source: ClinicalTrials.gov NCT03783091 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Feasibility of Clinical and Protocol Completion — 10; 10 Participants

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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