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A Trial of Vitamin B12 in Septic Shock — B12  

Septic Shock Clinical Trial

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

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03783091
Study type Interventional
Source Medical College of Wisconsin
Contact Jayshil J Patel, MD
Phone 414-955-7040
Email jpatel2@mcw.edu
Status Recruiting
Phase Phase 2
Start date August 5, 2019
Completion date December 2025
View Details
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