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Completed
NCT05752279
Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
Conditions: Diabetic Ketoacidosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 547
Sponsor: The George Institute
Location: Blacktown Hospital Blacktown New South Wales
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 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 \ 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 \
Source: ClinicalTrials.gov (NCT05752279). StuddyBuddy aggregates publicly available trial information.