Septic Shock
Conditions
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).
Interventions
DRUGHydroxocobalamin
Single IV administration of Vitamin B12
DRUGPlacebo
Single IV administration of saline
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Clinical and Protocol Completion | 28 days | Feasibility of completing clinical and laboratory protocols to the arm assigned |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hydrogen Sulfide Concentration | 30 minutes post infusion | Difference between pre- and post-dose hydrogen sulfide levels |
| Persistent Organ Dysfunction Syndrome (PODS) | 28 days | Prevalence of Persistent organ dysfunction syndrome (PODS) |
| Change in Vasopressor Dose | 3 hours | Vasopressor dose in mcg/kg/min (norepinephrine equivalents) |
| ICU Mortality | during ICU stay, up to 30 days | Intensive care unit mortality |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJayshil J Patel, MD
Medical College of Wisconsin
Participant flow
Recruitment details
20 patients from tertiary care medical and surgical intensive care units
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63 years |
| Norepinephrine equivalent dose at T0 | 0.29 micrograms per kilogram per minute |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
| SOFA score | 14 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 10 | 4 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
None listed