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Completed

NCT Number: NCT03783091

A Trial of Vitamin B12 in Septic Shock

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

Following informed consent from patient's legally authorized representative, patients will be randomized to hydroxocobalamin or saline. Patients will have blood samples drawn up to 3 hours pre-dose and 3 hours post-dose to measure for hydrogen sulfide levels. Patients will also be followed for 3 hours after study drug infusion to monitor and record vasopressor dependence in norepinephrine-equivalent dose. Patients will then be followed through their medical record for 28 days to determine persistent organ dysfunction syndrome (PODS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxocobalamin

Drug

Single IV administration of Vitamin B12

Other names: Cyanokit

Placebo

Drug

Single IV administration of saline

Other names: 200-250 mL of intravenous saline or dextrose

Primary outcomes

  1. Feasibility of Clinical and Protocol Completion

    Time frame: 28 days

    Feasibility of completing clinical and laboratory protocols to the arm assigned

Secondary outcomes

  1. Hydrogen Sulfide Concentration

    Time frame: 30 minutes post infusion

    Difference between pre- and post-dose hydrogen sulfide levels

  2. Persistent Organ Dysfunction Syndrome (PODS)

    Time frame: 28 days

    Prevalence of Persistent organ dysfunction syndrome (PODS)

  3. Change in Vasopressor Dose

    Time frame: 3 hours

    Vasopressor dose in mcg/kg/min (norepinephrine equivalents)

  4. ICU Mortality

    Time frame: during ICU stay, up to 30 days

    Intensive care unit mortality

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

A Phase II Double Blind Randomized Controlled Trial of High Dose Vitamin B12 in Septic Shock

Acronym: B12

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2018
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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