Sponsor protocol code: UniMS23_0017
EU trial-No.: 2025-523914-10-00

Indication: The target population are adult, critically ill patients (requiring treatment on an ICU) with acute kidney injury (KDIGO 2 or 3) and metabolic acidosis (pH ≤7.25).

Study Design: Multicenter, randomized controlled, double-blind, two-arm parallel-group trial with adaptive design

Therapy: 
Intervention arm: Intravenous infusion of sodium bicarbonate 8.4% weight by volume (w/v) + standard of care
Control arm: Intravenous infusion of placebo (balanced crystalloid, e.g., Sterofundin® ISO, other equivalent solutions may be used depending on local supply agreements) + standard of care

Primary objective:
To investigate the effect of sodium bicarbonate in critically ill patients with AKI and metabolic acidosis on long-term major adverse kidney events on day 90 (MAKE90)

Beteiligte Wissenschaftler:
Dr. rer. medic. Dipl.-Math. R. Koch
AOR Dr. Dipl.-Stat. J. Gerß

Studienleitung:
Univ.-Prof. Dr. med. A. Zarbock (Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie)

Förderung: DFG Projektnummer 538118253 (Fördervolumen ca. 3.120.000 €)