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Sodium Bicarbonate for Critically Ill Patients With Metabolic Acidosis and Acute Kidney Injury

Study acronym: ESCALATE
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2026 to May 7, 2026
    v3
  2. Primary endpoint(s) modifiedv2 Show 4 more changesShow less
    • Start date: Mar 2026 to May 2026
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: 4 to 5
    • Study title shortened, about 5 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07464431
Lead Sponsor Universität Münster
Collaborators: German Research Foundation
Conditions
(from sponsor)		 Acute Kidney Injury, Metabolic Acidosis, Critical Illness
Related terms Acidosis, Acute Kidney Injury, Critical Illness
Enrollment 660 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov