Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Institute
• Treatments: Plasma-lyte 148

Criteria

Inclusion Criteria:

• Patients in the ED with a primary diagnosis of moderate to severe DKA for whom both saline and Plasma-Lyte® 148 are considered appropriate fluids

• Blood glucose level > 14mmol/L

• pH < 7.25

• Serum bicarbonate <15 mmol/L

• Elevated anion gap > 12mEq/L

• Ketones positive on finger prick measurements

• In the judgement of the treating clinician critical care area admission is required

Exclusion Criteria:

• Age less than 18 years

• Patients who have received more than 2000ml of non study fluid prior to study enrolment

• Serum Na > 155 or <120 mmol/L

• Contraindication to either study fluid e.g. previous allergic reaction to Plasma-Lyte® 148

• Patients with hyperosmotic hyperglycaemic non-ketotic syndrome

• Other clinical conditions that preclude large volumes of fluid resuscitation

• Previous inclusion in BEST-DKA trial