Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

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).

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 fluidsBlood glucose level > 14mmol/LpH < 7.25Serum bicarbonate <15 mmol/LElevated anion gap > 12mEq/LKetones positive on finger prick measurementsIn the judgement of the treating clinician critical care area admission is requiredExclusion Criteria:Age less than 18 yearsPatients who have received more than 2000ml of non study fluid prior to study enrolmentSerum Na > 155 or <120 mmol/LContraindication to either study fluid e.g. previous allergic reaction to Plasma-Lyte® 148Patients with hyperosmotic hyperglycaemic non-ketotic syndromeOther clinical conditions that preclude large volumes of fluid resuscitationPrevious inclusion in BEST-DKA trial