Speaker
Ary Serpa Neto, MD, MSc, PhD, FCICM
Associate Professor
Co-Deputy Director, Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), Monash University
Intensivist and Director of Intensive Care Research, Austin Health
Keywords
Intensive Care Unit; MAKE30; Kidneys; Metabolic Acidosis; Sodium Bicarbonate
Key Points
- Metabolic acidosis affects roughly 10% of critically ill patients in the intensive care unit (ICU) and is associated with poor outcomes. The longer it persists, the more dangerous it becomes. There is evidence to suggest that treatment with a hypertonic sodium bicarbonate solution can improve outcomes.
- The Sodium Bicarbonate for Metabolic Acidosis in the ICU (SODa-BIC) trial aimed to test whether the use of sodium bicarbonate reduced major adverse kidney events in adults with metabolic acidosis receiving vasopressor support. They conducted the trial across 7 countries to increase patient volume and external validity. The primary outcome was major adverse kidney events within 30 days.
- The SODa-BIC research team concluded that sodium bicarbonate therapy did not reduce major adverse kidney events in their target population.
Discussion Themes
Double-blinding was chosen to eliminate bias in subjective decisions, such as the initiation of renal replacement therapy. Completing a pilot study with 30 patients was essential for securing major funding, as it proved the trial’s feasibility and the efficacy of the blinding strategy.
The research team had to develop an in-house solution using 5% dextrose because sodium bicarbonate is incompatible with other common fluids.
In Australia and New Zealand, researchers utilize a formal process where they present trial ideas to the clinical community for critique and endorsement before applying for funding. This improves trial design and site engagement.
Next steps include an individual patient data meta-analysis combining SODa-BIC data with that of similar trials and a potential new trial specifically targeting patients with advanced kidney injury.