Evaluating the clinical effectiveness of sodium bicarbonate for critically ill patients with acute kidney injury (ESCALATE) - Randomized Double Blind Placebo Controlled Trial

• Applicant: Professor Dr. Alexander Zarbock
• Subject Area: Anaesthesiology
• Term: since 2025
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 538117253

More than 200,000 critically ill adults are admitted to critical care each year in Germany. Around half have a sudden worsening in kidney function that happens as part of their illness defined as acute kidney injury (AKI). This rapid decline in kidney function frequently causes more acid to build up in the blood (a process known as acidosis) which can cause further harm. Critically ill patients with acidosis (commonly defined as a pH <7.30 with PaCO2 <6.5 kPa and bicarbonate ≤20 mmol/L) in the context of also having AKI have a very poor prognosis, with a 90-day mortality of 53%. In these patients, kidney replacement therapy (KRT) is the most commonly used treatment. Another option is to treat the acidosis directly by administering “buffer” solutions (e.g. sodium bicarbonate), with the aim of raising extracellular pH to restore cardiovascular function and oxygen delivery to tissues. This has the potential to both increase survival and avoid KRT, which is invasive, expensive and resource-intensive. The “Evaluating the clinical effectiveness of sodium bicarbonate for critically ill patients with acute kidney injury (ESCALATE)” multicenter, double-blinded RCT will address the clinically important question of whether in critically ill adults with metabolic acidosis and AKI, is treatment with IV 8.4% weight by volume (w/v) sodium bicarbonate superior to placebo in terms of the composite endpoint major adverse kidney events (MAKE) at day 90 (composite of death from any cause, receipt of KRT, or persistent renal dysfunction (defined as a creatinine value ≥200% of the baseline value). This evaluation will have a large and immediate impact on clinical practice and on patient outcomes in Germany and worldwide.

• DFG Programme: Clinical Trials
• Co-Investigators: Professor Dr. Stefan Kluge; Professor Dr. Peter Rosenberger