A Trial of Vitamin B12 in Septic Shock

Medical College of Wisconsin

Status and phase: Completed; Phase 2

Conditions: Septic Shock

Treatments: Drug: Placebo; Drug: Hydroxocobalamin

Study type: Interventional

Funder types: Other

Identifiers

NCT03783091

32950

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Hydroxocobalamin

Experimental group

Description:

Single IV infusion administered over a 10-15 minute period

Treatment:

Drug: Hydroxocobalamin

Saline Placebo

Placebo Comparator group

Description:

Single IV saline administered over a 10-15 minute period.

Treatment:

Drug: Placebo