A Trial of Vitamin B12 in Septic Shock

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Hydroxocobalamin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxocobalamin<br>Single IV infusion administered over a 10-15 minute period | Drug: Hydroxocobalamin<br>* Single IV administration of Vitamin B12<br>* Other names: Cyanokit;|
| Placebo Comparator: Saline Placebo<br>Single IV saline administered over a 10-15 minute period. | Drug: Placebo<br>* Single IV administration of saline<br>* Other names: 200-250 mL of intravenous saline or dextrose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of completing clinical and laboratory protocols | Feasibility of completing clinical and laboratory protocols | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydrogen Sulfide Concentration | Difference between pre- and post-dose hydrogen sulfide levels | 3 hours | 
| Persistent Organ Dysfunction Syndrome (PODS) | Prevalence of Persistent organ dysfunction syndrome (PODS) | 28 days | 
| Change in vasopressor dose | Vasopressor dose in mcg/kg/min (norepinephrine equivelents) | 3, 24, and 48 hours | 
| Mortality | Intensive care unit and hospital mortality | 28 days |