Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
ConditionDiabetic Ketoacidosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe George Institute
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Plasma-Lyte 148
- 0.9% sodium chloride
Treatment groups
680 Participants
are divided into 2 treatment groupsLocations
21Blacktown Hospital2148, BlacktownNew South Wales, Australia
Camperdown Hospital2050, CamperdownNew South Wales, Australia
Dubbo Base Hospital2830, DubboNew South Wales, Australia
St George Hospital2217, KogarahNew South Wales, Australia
Sponsors and collaborators
The George Institute
Lead sponsor
Source ClinicalTrials.gov