Clincosm LogoSign in Get a demo

A Trial of Vitamin B12 in Septic Shock

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Recruiting
CT.gov ID
NCT03783091
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
75.9
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
A Phase II Double Blind Randomized Controlled Trial of High Dose Vitamin B12 in Septic Shock
Actual Study Start Date :
Aug 5, 2019
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hydroxocobalamin

Single IV infusion administered over a 10-15 minute period

Drug: Hydroxocobalamin
Single IV administration of Vitamin B12
Other Names:
  • Cyanokit

    		•
    Placebo Comparator: Saline Placebo

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

    Drug: Placebo
    Single IV administration of saline
    Other Names:
  • 200-250 mL of intravenous saline or dextrose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of completing clinical and laboratory protocols [28 days]

      Feasibility of completing clinical and laboratory protocols

    Secondary Outcome Measures

    1. Hydrogen Sulfide Concentration [3 hours]

      Difference between pre- and post-dose hydrogen sulfide levels

    2. Persistent Organ Dysfunction Syndrome (PODS) [28 days]

      Prevalence of Persistent organ dysfunction syndrome (PODS)

    3. Change in vasopressor dose [3, 24, and 48 hours]

      Vasopressor dose in mcg/kg/min (norepinephrine equivelents)

    4. Mortality [28 days]

      Intensive care unit and hospital mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Medical College of Wisconsin

    Investigators

    • Principal Investigator: Jayshil J Patel, MD, Medical College of Wisconsin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jayshil J. Patel, MD, Associate Professor of Medicine, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT03783091
    Other Study ID Numbers:
    • 32950
    First Posted:
    Dec 20, 2018
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Shock, Septic
    Shock
    Hydroxocobalamin
    Vitamin B 12

    Study Results

    No Results Posted as of Dec 15, 2021