Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

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 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

Conditions2

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