A Trial of Vitamin B12 in Septic Shock (B12)

November 30, 2021 updated by: Jayshil J. Patel, MD, Medical College of Wisconsin

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jayshil J Patel, MD
  • Phone Number: 414-955-7040
  • Email: jpatel2@mcw.edu

Study Contact Backup

  • Name: Jeanette Graf, BS
  • Phone Number: 414-955-6987
  • Email: jgraf@mcw.edu

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Jayshil J Patel, MD
          • Phone Number: 414-955-7040
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of completing clinical and laboratory protocols
Time Frame: 28 days
Feasibility of completing clinical and laboratory protocols
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hydrogen Sulfide Concentration
Time Frame: 3 hours
Difference between pre- and post-dose hydrogen sulfide levels
3 hours
Persistent Organ Dysfunction Syndrome (PODS)
Time Frame: 28 days
Prevalence of Persistent organ dysfunction syndrome (PODS)
28 days
Change in vasopressor dose
Time Frame: 3, 24, and 48 hours
Vasopressor dose in mcg/kg/min (norepinephrine equivelents)
3, 24, and 48 hours
Mortality
Time Frame: 28 days
Intensive care unit and hospital mortality
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2019

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 20, 2018

Study Record Updates

Last Update Posted (Actual)

December 15, 2021

Last Update Submitted That Met QC Criteria

November 30, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32950

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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