Sodium Bicarbonate Fails to Improve Survival or Kidney Outcomes in Critical Illness: SODa-BIC Trial Finds
Australia: A randomized, double-blind SODa-BIC trial found that although sodium bicarbonate rapidly corrected metabolic acidosis, it did not reduce 30-day mortality or major kidney-related adverse events in critically ill patients receiving vasopressor support. Unlike earlier open-label studies that suggested potential renal benefits, no significant clinical advantage was observed, including across all prespecified subgroups, though the trial may have been underpowered to detect smaller effects.
These findings, published in The New England Journal of Medicine, indicate that routine sodium bicarbonate therapy does not improve survival or kidney outcomes in critically ill patients with metabolic acidosis receiving vasopressor support. The study was conducted by Ary Serpa Neto of Monash University's Australian and New Zealand Intensive Care Research Centre, Melbourne, Australia, and colleagues.
Metabolic acidosis is common in critically ill patients and is linked to organ dysfunction, acute kidney injury, and increased mortality. Although sodium bicarbonate is frequently used to correct acidemia, its effect on meaningful clinical outcomes remains uncertain.
To assess its effectiveness, researchers conducted the SODa-BIC trial, a pragmatic, adaptive, randomized, double-blind study involving critically ill adults with metabolic acidosis who were receiving vasopressor support in the ICU.
Eligible patients had a pH below 7.30 and a base excess of −4 mmol/L or lower and were randomly assigned to receive either intravenous sodium bicarbonate or a placebo (5% dextrose). Treatment was administered for up to five hours, with dosing adjusted to achieve predefined acid-base targets.
The trial enrolled 500 patients from 55 ICUs across seven countries, including 245 assigned to sodium bicarbonate and 255 to placebo. The primary outcome was a major adverse kidney event within 30 days, defined as death, the need for renal replacement therapy, or persistent kidney dysfunction.
The following were the key findings:
- Major adverse kidney events within 30 days occurred in 40.2% of patients receiving sodium bicarbonate and 39.4% of those receiving placebo, showing no significant difference between groups.
- Renal replacement therapy was required in 16.8% of patients in the sodium bicarbonate group compared with 20.9% in the placebo group, with no statistically significant benefit.
- In-hospital mortality by day 30 was similar between the groups, affecting 25.4% of patients treated with sodium bicarbonate and 24.0% of those receiving placebo.
- Sodium bicarbonate corrected metabolic acidosis more rapidly than placebo but did not improve clinically important outcomes.
- Treatment-related adverse events were infrequent, occurring in four patients (1.6%) in the sodium bicarbonate group and in none of the placebo-treated patients.
The researchers concluded that sodium bicarbonate therapy did not reduce the risk of major adverse kidney events, dialysis use, or death among critically ill patients with metabolic acidosis receiving vasopressor support. These findings challenge the routine use of sodium bicarbonate for this indication and highlight the need for further research to identify patient populations that may derive meaningful benefit from the treatment.
Reference:
DOI: 10.1056/NEJMoa2600526
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