A Study Comparing Plasma-Lyte 148 and 0.9% Sodium Chloride Fluids for Adults with Moderate to Severe Diabetic Ketoacidosis in Emergency and Critical Care

What this Trial Is About

This trial investigates whether fluid therapy with Plasma-Lyte48 increases the number of days alive and out of hospital by day 28 compared to 0.9% sodium chloride saline in critically ill patients with moderate to severe diabetic ketoacidosis DKA admitted to emergency departments and critical care units. DKA is a serious complication of diabetes, and hospital admissions for this condition have risen notably in recent years. Current treatment guidelines rely on limited evidence, creating a need for clearer information on the best fluid therapy approach. Participants receive either Plasma-Lyte48 or 0.9% saline as intravenous fluids for resuscitation during two 12-month periods across 20 hospitals, with a one-month break between periods. Each hospital switches fluids after the first period. The fluids are blinded and provided by Baxter Healthcare, with treatments continuing until discharge from critical care or up to 72 hours. Additional therapies, including glucose solutions and electrolyte supplements, are used as needed based on clinical judgment. During the study, patients are monitored for hospital-free days up to 28 days after enrollment, with telephone follow-up to collect information. Secondary outcomes include ICU-free days, readmissions, kidney function, mental status changes, ketosis resolution time, insulin use, and potassium replacement. The study involves consumer representatives and aims to provide evidence to improve DKA management. Total participation involves treatment and follow-up over 28 days post-enrollment.

Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis