Clinical trial NCT03783091: A Trial of Vitamin B12 in Septic Shock
Official title: A Phase II Double Blind Randomized Controlled Trial of High Dose Vitamin B12 in Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Septic Shock
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

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

Primary outcomes:
measure: Feasibility of completing clinical and laboratory protocols
timeFrame: 28 days
Secondary outcomes:
measure: Hydrogen Sulfide Concentration
timeFrame: 3 hours
measure: Persistent Organ Dysfunction Syndrome (PODS)
timeFrame: 28 days
measure: Change in vasopressor dose
timeFrame: 3, 24, and 48 hours
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Jayshil J Patel, MD
role: PRINCIPAL_INVESTIGATOR
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