A Trial of Vitamin B12 in Septic Shock

Phase 2

Completed

• Conditions: Septic Shock
• Interventions: Drug: Placebo; Drug: Hydroxocobalamin

• Registration Number: NCT03783091
• Lead Sponsor: Medical College of Wisconsin

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).

Study Timeline

• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-20
• Study Start: 2019-08-05
• Primary Completion: 2023-02-23
• Study Completion: 2023-02-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline Placebo	Placebo	Single IV saline administered over a 10-15 minute period.
Hydroxocobalamin	Hydroxocobalamin	Single IV infusion administered over a 10-15 minute period

Primary Outcome Measures

Name	Time	Method
Feasibility of completing clinical and laboratory protocols	28 days	Feasibility of completing clinical and laboratory protocols

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States