Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-08-05
Study Completion Date
2023-02-23
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Septic Shock
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
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.
Study Groups
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Hydroxocobalamin
Single IV infusion administered over a 10-15 minute period
Group Type
EXPERIMENTAL
Hydroxocobalamin
Intervention Type
DRUG
Single IV administration of Vitamin B12
Saline Placebo
Single IV saline administered over a 10-15 minute period.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Single IV administration of saline
Interventions
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Hydroxocobalamin
Single IV administration of Vitamin B12
Intervention Type
DRUG
Placebo
Single IV administration of saline
Intervention Type
DRUG
Other Intervention Names
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Cyanokit
200-250 mL of intravenous saline or dextrose
Eligibility Criteria
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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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Medical College of Wisconsin
OTHER
Sponsor Role
lead
Responsible Party
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Jayshil J. Patel, MD
Associate Professor of Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jayshil J Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Site Status
Countries
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United States
References
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Reference Type
DERIVED
Other Identifiers
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32950
Identifier Type: -
Identifier Source: org_study_id
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