Sodium Bicarbonate for Critically Ill Patients With Metabolic Acidosis and Acute Kidney Injury (NCT07464431) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Sodium Bicarbonate for Critically Ill Patients With Metabolic Acidosis and Acute Kidney Injury
660 participantsStarted 2026-05
Plain-language summary
The study investigates whether sodium bicarbonate is able to reduce the occurrence of major adverse kidney events on day 90 (MAKE90) in critically ill patients with metabolic acidosis and acute kidney injury (AKI). While its efficacy in this context has been suggested in a subgroup analysis of the BICAR-ICU trial it has not been confirmed in a double-blinded randomized controlled trial to date.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult ≥ 18 years
✓. Critically ill patients (requiring treatment on an ICU or IMC)
✓. Metabolic acidosis, defined as all of the following:
✓. Arterial pH ≤7.25
✓. PaCO2 \< 6.5kPa (\<49 mmHg)
✓. Standard bicarbonate ≤20 mmol/L
✓. Standard Base Excess \<-2
✓. AKI stage 2 or 3 of the KDIGO classification
Exclusion criteria
✕. Pregnant or breastfeeding patients
✕. Respiratory acidosis (acute or chronic) \[dynamic, and if corrected, patient may be reconsidered for the trial\]
✕. Patients on KRT, or KRT immediately indicated and treating clinician(s) unwilling to defer
✕. Deemed unsuitable for KRT
✕. High output stoma/ileostomy
✕. Percutaneous biliary drainage
✕. End stage kidney failure defined as documented eGFR \<15ml/min/1.73m 2 prior to onset of this acute illness or end stage kidney disease (ESKD) on dialysis
What they're measuring
1
MAKE90 (consisting of mortality, dialysis within 90 days, persistent renal dysfunction (defined as serum creatinine ≥ 2x compared to baseline value at day 90)