drugset / Trial / NCT05752279

Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

NCT05752279

Phase 3 Recruiting 680 enrolled The George Institute
RandomizedCrossoverTriple-blindTreatment

Summary

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).

Timeline

Start
2024-03-14
Primary completion
2026-07
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Plasmalyte Other / unclassified 1000 ml Intravenous
Comparator sodium chloride Unknown 1000 ml Intravenous

Indications