Hemodynamics, fluids & transfusion
Sodium Bicarbonate for Metabolic Acidosis in the ICU: Results of a Pilot Randomized Double-Blind Clinical Trial
Primary result · Hours alive and free of vasopressorResult — go to the resultMedian difference 35.07 95% CI −9.14 to 79.28Authors' conclusion
The findings confirm the feasibility of a larger phase III sodium bicarbonate trial; eligibility criteria may require modification to facilitate recruitment.
Study context
- Population
- Adults ≥18 years within 48 hours of ICU admission, receiving a vasopressor, with metabolic acidosis (pH < 7.30, BE < −4 mEq/L, PaCO2 < 45 mm Hg); 8 ICUs in Australia, New Zealand and Japan
- Participants
- 30 adults
- Comparison
- Sodium bicarbonate vs placebo
- Primary endpoint
- Hours alive and free of vasopressors (primary clinical outcome); feasibility: eligibility, recruitment rate, protocol compliance, acid-base group separation
- Follow-up
- Day 7
Methodological detailsdouble-blind, investigator-initiated, parallel-group, multicentre, Recruited April 2021 to August 2022
- Double-blind
- Investigator-initiated
- Parallel-group
- Multicentre
- Recruited April 2021 to August 2022
Primary result
Hours alive and free of vasopressor
Median difference
35.07
95% CI −9.14 to 79.28
P = 0.131
By group
Sodium bicarbonate vs Placebo
median difference 35.07 (95% CI −9.14 to 79.28); P = 0.131
As reported in the abstract
- Recruitment rate
- 1.9 patients per month
- Enrollment-to-screening ratio
- 0.13
Further findings
| Outcome | Median difference (hr) (95% CI) | P value | |
|---|---|---|---|
| Time until BE correction | −45.86 (−63.11 to −28.61) | P < 0.001 | |
| Time until pH correction | −10.69 (−19.16 to −2.22) | P = 0.020 | |
| −100−50050Difference, hr (linear scale) |
| Outcome | Median difference (mmol/L) (95% CI) | P value | |
|---|---|---|---|
| Mean bicarbonate levels · first 24 hours | 6.50 (4.18–8.82) | P < 0.001 | |
| −50510Difference, mmol/L (linear scale) |
Recurrence of metabolic acidosis · first 7 days
P < 0.001
Safety
- No adverse events reported
Original publication
Sodium Bicarbonate for Metabolic Acidosis in the ICU: Results of a Pilot Randomized Double-Blind Clinical Trial. Crit Care Med. Published 9 June 2023. doi:10.
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