Evaluating the clinical effectiveness of sodium bicarbonate for critically ill patients with metabolic acidosis and acute kidney injury

Condition studied

Critical illness, Acute kidney injury, Metabolic acidosis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Major adverse kidney events (MAKE90) Binary endpoint consisting of mortality or any KRT within 90 days after randomization or persistent renal dysfunction (creatinine value at day 90 ≥200% of baseline value) at day 90

Endpoint detail

90-day all-cause mortality (%), Elevation of the creatinine level to ≥200% of baseline value at day 90 (one measurement between day 80 and 120 after randomization), Receipt of any form of KRT within the 90-day time period after randomization, Kidney Replacement Therapy (KRT)-dependence at day 90 after randomization, KRT-free days, defined as difference between number of days alive and number of days receiving KRT of any form between randomization and day 90