NCT03783091

A Trial of Vitamin B12 in Septic Shock

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	Hydroxocobalamin	Single IV administration of Vitamin B12
DRUG	Placebo	Single IV administration of saline

Timeline

• Start date: 2019-08-05
• Primary completion: 2023-02-23
• Completion: 2023-02-23
• First posted: 2018-12-20
• Last updated: 2024-11-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study