Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
Balanced Multi-electrolyte Solution Versus 0.9% Sodium Chloride as Fluid Therapy for Patients Presenting With Moderate to Severe Diabetic Ketoacidosis
The George Institute
680 participants
Mar 14, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria7
- 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 Criteria7
- 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
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Interventions
Plasma-Lyte® 148 intravenous fluid for resuscitation in patients with keto-acidosis
0.9% sodium chloride intravenous fluid for resuscitation in patients with keto-acidosis
Locations(21)
View Full Details on ClinicalTrials.gov
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NCT05752279