Trial Outcomes & Findings for A Trial of Vitamin B12 in Septic Shock (NCT NCT03783091)
NCT ID: NCT03783091
Last Updated: 2026-05-27
Results Overview
Feasibility of completing clinical and laboratory protocols to the arm assigned
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
28 days
Results posted on
2026-05-27
Participant Flow
20 patients from tertiary care medical and surgical intensive care units
Participant milestones
| Measure |
Hydroxocobalamin
Single IV infusion administered over a 10-15 minute period
|
Saline Placebo
Single IV saline administered over a 10-15 minute period.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of Vitamin B12 in Septic Shock
Baseline characteristics by cohort
| Measure |
A Single 5-gram Dose of Hydroxocobalamin
n=10 Participants
Participants randomized to hydroxocobalamin received a single 5-gram IV infusion, administered over a 10-15-minute period
|
Equivalent Volume 0.9% Saline Placebo
n=10 Participants
Participants randomized to placebo received an equivalent volume 0.9% saline placebo, administered over a 10-15 minute period
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=51 Participants
|
57 years
n=14 Participants
|
63 years
n=65 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=51 Participants
|
5 Participants
n=14 Participants
|
10 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=51 Participants
|
5 Participants
n=14 Participants
|
10 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=51 Participants
|
8 Participants
n=14 Participants
|
16 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Norepinephrine equivalent dose at T0
|
0.29 micrograms per kilogram per minute
n=51 Participants
|
0.34 micrograms per kilogram per minute
n=14 Participants
|
0.32 micrograms per kilogram per minute
n=65 Participants
|
|
SOFA score
|
14 units on a scale
n=51 Participants
|
14 units on a scale
n=14 Participants
|
14 units on a scale
n=65 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: critically ill adults with septic shock
Feasibility of completing clinical and laboratory protocols to the arm assigned
Outcome measures
| Measure |
Hydroxocobalamin
n=10 Participants
Single IV infusion administered over a 10-15 minute period
Hydroxocobalamin: Single IV administration of Vitamin B12
|
Saline Placebo
n=10 Participants
Single IV saline administered over a 10-15 minute period.
Placebo: Single IV administration of saline
|
|---|---|---|
|
Feasibility of Clinical and Protocol Completion
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 30 minutes post infusionPopulation: critically ill adults with septic shock
Difference between pre- and post-dose hydrogen sulfide levels
Outcome measures
| Measure |
Hydroxocobalamin
n=10 Participants
Single IV infusion administered over a 10-15 minute period
Hydroxocobalamin: Single IV administration of Vitamin B12
|
Saline Placebo
n=10 Participants
Single IV saline administered over a 10-15 minute period.
Placebo: Single IV administration of saline
|
|---|---|---|
|
Hydrogen Sulfide Concentration
|
-13 micromolar
Interval -17.0 to -6.0
|
-3 micromolar
Interval -11.0 to 1.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: critically ill adults with septic shock
Prevalence of Persistent organ dysfunction syndrome (PODS)
Outcome measures
| Measure |
Hydroxocobalamin
n=10 Participants
Single IV infusion administered over a 10-15 minute period
Hydroxocobalamin: Single IV administration of Vitamin B12
|
Saline Placebo
n=10 Participants
Single IV saline administered over a 10-15 minute period.
Placebo: Single IV administration of saline
|
|---|---|---|
|
Persistent Organ Dysfunction Syndrome (PODS)
|
5 number of patients with PODS
|
4 number of patients with PODS
|
SECONDARY outcome
Timeframe: 3 hoursPopulation: critically ill adults with septic shock
Vasopressor dose in mcg/kg/min (norepinephrine equivalents)
Outcome measures
| Measure |
Hydroxocobalamin
n=10 Participants
Single IV infusion administered over a 10-15 minute period
Hydroxocobalamin: Single IV administration of Vitamin B12
|
Saline Placebo
n=10 Participants
Single IV saline administered over a 10-15 minute period.
Placebo: Single IV administration of saline
|
|---|---|---|
|
Change in Vasopressor Dose
|
-28 micrograms per kilogram per minute
Interval -677.0 to -12.0
|
10 micrograms per kilogram per minute
Interval -14.0 to 49.0
|
SECONDARY outcome
Timeframe: during ICU stay, up to 30 daysIntensive care unit mortality
Outcome measures
| Measure |
Hydroxocobalamin
n=10 Participants
Single IV infusion administered over a 10-15 minute period
Hydroxocobalamin: Single IV administration of Vitamin B12
|
Saline Placebo
n=10 Participants
Single IV saline administered over a 10-15 minute period.
Placebo: Single IV administration of saline
|
|---|---|---|
|
ICU Mortality
|
3 number of patients who died in the ICU
|
4 number of patients who died in the ICU
|
Adverse Events
Hydroxocobalamin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Saline Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place