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A Trial of Vitamin B12 in Septic Shock (B12)

Primary Purpose

Septic Shock

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxocobalamin
Placebo
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydroxocobalamin

Saline Placebo

Arm Description

Single IV infusion administered over a 10-15 minute period

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

Outcomes

Primary Outcome Measures

Feasibility of completing clinical and laboratory protocols
Feasibility of completing clinical and laboratory protocols

Secondary Outcome Measures

Hydrogen Sulfide Concentration
Difference between pre- and post-dose hydrogen sulfide levels
Persistent Organ Dysfunction Syndrome (PODS)
Prevalence of Persistent organ dysfunction syndrome (PODS)
Change in vasopressor dose
Vasopressor dose in mcg/kg/min (norepinephrine equivelents)
Mortality
Intensive care unit and hospital mortality

Full Information

First Posted
December 19, 2018
Last Updated
November 30, 2021
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT03783091
Brief Title
A Trial of Vitamin B12 in Septic Shock
Acronym
B12
Official Title
A Phase II Double Blind Randomized Controlled Trial of High Dose Vitamin B12 in Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydroxocobalamin
Arm Type
Experimental
Arm Description
Single IV infusion administered over a 10-15 minute period
Arm Title
Saline Placebo
Arm Type
Placebo Comparator
Arm Description
Single IV saline administered over a 10-15 minute period.
Intervention Type
Drug
Intervention Name(s)
Hydroxocobalamin
Other Intervention Name(s)
Cyanokit
Intervention Description
Single IV administration of Vitamin B12
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
200-250 mL of intravenous saline or dextrose
Intervention Description
Single IV administration of saline
Primary Outcome Measure Information:
Title
Feasibility of completing clinical and laboratory protocols
Description
Feasibility of completing clinical and laboratory protocols
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Hydrogen Sulfide Concentration
Description
Difference between pre- and post-dose hydrogen sulfide levels
Time Frame
3 hours
Title
Persistent Organ Dysfunction Syndrome (PODS)
Description
Prevalence of Persistent organ dysfunction syndrome (PODS)
Time Frame
28 days
Title
Change in vasopressor dose
Description
Vasopressor dose in mcg/kg/min (norepinephrine equivelents)
Time Frame
3, 24, and 48 hours
Title
Mortality
Description
Intensive care unit and hospital mortality
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jayshil J Patel, MD
Phone
414-955-7040
Email
jpatel2@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanette Graf, BS
Phone
414-955-6987
Email
jgraf@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayshil J Patel, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayshil J Patel, MD
Phone
414-955-7040
First Name & Middle Initial & Last Name & Degree
Jennifer Peterson, PhD
Phone
414-955-7085
Email
jenpeterson@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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A Trial of Vitamin B12 in Septic Shock

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