A Trial of Vitamin B12 in Septic Shock

Septic Shock Clinical Trial

— B12  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03783091
• Other study ID #: 32950
• Status: Recruiting
• Phase: Phase 2
• Start date: August 5, 2019
• Est. completion date: December 2025

Study information

• Verified date: November 2021
• Source: Medical College of Wisconsin
• Contact: Jayshil J Patel, MD
• Phone: 414-955-7040
• Email: jpatel2[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Hydroxocobalamin
Single IV administration of Vitamin B12
• Placebo
Single IV administration of saline

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of completing clinical and laboratory protocols	Feasibility of completing clinical and laboratory protocols	28 days
Secondary	Hydrogen Sulfide Concentration	Difference between pre- and post-dose hydrogen sulfide levels	3 hours
Secondary	Persistent Organ Dysfunction Syndrome (PODS)	Prevalence of Persistent organ dysfunction syndrome (PODS)	28 days
Secondary	Change in vasopressor dose	Vasopressor dose in mcg/kg/min (norepinephrine equivelents)	3, 24, and 48 hours
Secondary	Mortality	Intensive care unit and hospital mortality	28 days