A Trial of Vitamin B12 in Septic Shock

NCT03783091 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 32950
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Feasibility of completing clinical and laboratory protocols

  Feasibility of completing clinical and laboratory protocols

  28 days

Secondary Outcomes (4)

• Hydrogen Sulfide Concentration

  3 hours

• Persistent Organ Dysfunction Syndrome (PODS)

  28 days

• Change in vasopressor dose

  3, 24, and 48 hours

• Mortality

  28 days

Study Arms (2)

Hydroxocobalamin

EXPERIMENTAL

Single IV infusion administered over a 10-15 minute period

Drug: Hydroxocobalamin

Saline Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Hydroxocobalamin DRUG

Single IV administration of Vitamin B12

Also known as: Cyanokit

Hydroxocobalamin

Placebo DRUG

Single IV administration of saline

Also known as: 200-250 mL of intravenous saline or dextrose

Saline Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of calcium oxaluria

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

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MeSH Terms

Conditions

Shock, Septic

Interventions

Hydroxocobalamin; Vitamin B 12; Glucose

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Jayshil J Patel, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Vitamin B12a is bright red and excreted in the urine. Due to this, patient allocation cannot be masked for patients or individuals who may care for them.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 20, 2018
• Study Start: August 5, 2019
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)