Balanced Multi-electrolyte Solution Versus 0.9% Sodium Chloride as Fluid Therapy for Patients Presenting With Moderate to Severe Diabetic Ketoacidosis

TGI CCP-2378-352

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).

2024-03-01

2026-04-01

2026-06-01

Not yet recruiting

Early phase I

680

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 680, 'type': 'ESTIMATED'}}

2024-01-18