High-Dose IV Hydroxocobalamin (Vitamin B12) in Septic Shock: A Double-Blind, Allocation-Concealed, Placebo-Controlled Single-Center Pilot Randomized Controlled Trial (The Intravenous Hydroxocobalamin in Septic Shock Trial)
Authors' conclusion
This pilot trial established favorable feasibility metrics.
Study context
- Population
- Critically ill adults with septic shock meeting Sepsis 3 criteriarandomized 1:1
- Participants
- 20 adults
- Comparison
- Single 5-g dose of high-dose IV hydroxocobalamin vs placebo
- Primary endpoint
- Study feasibility (enrollment rate, clinical and laboratory compliance rate, contamination rate)
Methodological detailsphase 2, pilot, single-centre, double-blind, allocation-concealed, placebo-controlled, parallel-group
- Phase 2
- Pilot
- Single-centre
- Double-blind
- Allocation-concealed
- Placebo-controlled
- Parallel-group
Primary result
As reported in the abstract
Study feasibility
Enrollment rate (20 patients over 19 months), patients per month
1.05
Protocol adherence rate
100%
Contamination
0
Secondary outcomes
| Outcome | High-dose IV hydroxocobalamin | Placebo | P value |
|---|---|---|---|
| Change in vasopressor dose, randomization to postinfusion | −36% | 4% | P < 0.001 |
| Change in vasopressor dose, randomization to 3-h postinfusion | −28% | 10% | P = 0.019 |
| Change in plasma H2S level · 45 mins | −0.80 ± 1.73 μM | −0.21 ± 0.64 μM | P = 0.3 |
Safety
- No serious adverse events with high-dose IV hydroxocobalamin
Original publication
High-Dose IV Hydroxocobalamin (Vitamin B12) in Septic Shock: A Double-Blind, Allocation-Concealed, Placebo-Controlled Single-Center Pilot Randomized Controlled Trial (The Intravenous Hydroxocobalamin in Septic Shock Trial). Chest. Published 26 September 2022. doi:10.
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