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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523914-10-00
Enrollment
660
Registered
2026-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute kidney injury, Critical illness, Metabolic acidosis

Brief summary

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

Detailed description

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

Interventions

DRUGJonosteril Infusionslösung
DRUGElektrolyt-Infusionslösung 153 Gesamtkationen/-anionen 153 mval/l
DRUGInfusionslösung zur intravenösen Anwendung
DRUGSODIUM HYDROGEN CARBONATE
DRUGSterofundin ISO Infusionslösung
DRUGRinger-Infusionslösung B. Braun

Sponsors

Universitaet Muenster
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 18, 2026