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Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

Study acronym: BEST-DKA
StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Final enrollment: 547 participants (planned 680) · Primary completion date changed from estimate of Jul 2026 to Jul 1, 2026 · Study completion date changed from estimate of Jul 2026 to Jul 31, 2026 · 3 more Show 6 more changesShow less
    • Final enrollment: 547 participants (planned 680)
    • Primary completion date changed from estimate of Jul 2026 to Jul 1, 2026
    • Study completion date changed from estimate of Jul 2026 to Jul 31, 2026
    • Study description revised
    • Study sites revised (21)
    • Eligibility criteria expanded, about 3 words
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 2 to 21 · Primary completion date: Apr 2026 to Jul 2026 · Completion date: Jun 2026 to Jul 2026 · 1 morev3 Show 4 more changesShow less
    • Study sites: 2 to 21
    • Primary completion date: Apr 2026 to Jul 2026
    • Completion date: Jun 2026 to Jul 2026
    • Start date changed from estimate of Mar 2024 to Mar 14, 2024
  3. Primary completion date: Aug 2025 to Apr 2026 Start date: Apr 2023 to Mar 2024 · Completion date: Sep 2025 to Jun 2026v2 Show 2 more changesShow less
    • Start date: Apr 2023 to Mar 2024
    • Completion date: Sep 2025 to Jun 2026
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this blinded, cluster cross-over, randomised controlled trial is to determine whether fluid therapy with Plasma-Lyte® 148 increases the number of days alive and days out of hospital to day-28 compared to 0.9% sodium chloride ('0.9% saline') in critically ill patients presenting to the Emergency Department (ED) and deemed to require admission to a critical care area (ICU, HDU) with moderate to severe diabetic ketoacidosis (DKA).
Trial Details
NCT Number NCT05752279
Lead Sponsor The George Institute
Conditions Diabetic Ketoacidosis
Enrollment 547 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov