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A Trial of Vitamin B12 in Septic Shock (B12)

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ClinicalTrials.gov Identifier: NCT03783091
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
Jayshil J. Patel, MD, Medical College of Wisconsin

Study Description
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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
Septic Shock Drug: Hydroxocobalamin Drug: Placebo 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 5, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins Shock

Arms and Interventions
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Arm Intervention/treatment
Experimental: Hydroxocobalamin
Single IV infusion administered over a 10-15 minute period
 Drug: Hydroxocobalamin
Single IV administration of Vitamin B12
Other Name: Cyanokit
Placebo Comparator: Saline Placebo
Single IV saline administered over a 10-15 minute period.
 Drug: Placebo
Single IV administration of saline
Other Name: 200-250 mL of intravenous saline or dextrose


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of completing clinical and laboratory protocols [ Time Frame: 28 days ]
    Feasibility of completing clinical and laboratory protocols


Secondary Outcome Measures :
  1. Hydrogen Sulfide Concentration [ Time Frame: 3 hours ]
    Difference between pre- and post-dose hydrogen sulfide levels

  2. Persistent Organ Dysfunction Syndrome (PODS) [ Time Frame: 28 days ]
    Prevalence of Persistent organ dysfunction syndrome (PODS)

  3. Change in vasopressor dose [ Time Frame: 3, 24, and 48 hours ]
    Vasopressor dose in mcg/kg/min (norepinephrine equivelents)

  4. Mortality [ Time Frame: 28 days ]
    Intensive care unit and hospital mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783091


Contacts
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Contact: Jayshil J Patel, MD 414-955-7040 jpatel2@mcw.edu
Contact: Jeanette Graf, BS 414-955-6987 jgraf@mcw.edu

Locations
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United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jayshil J Patel, MD    414-955-7040      
Contact: Jennifer Peterson, PhD    414-955-7085    jenpeterson@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Jayshil J Patel, MD Medical College of Wisconsin
More Information
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Publications:

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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: December 20, 2018    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
 Hydroxocobalamin
Vitamin B 12
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs