drugset / Trial / NCT05752279
Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Plasmalyte | Other / unclassified | 1000 ml | Intravenous |
| Comparator | sodium chloride | Unknown | 1000 ml | Intravenous |