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Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
Sponsor: The George Institute
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).
Official title: Balanced Multi-electrolyte Solution Versus 0.9% Sodium Chloride as Fluid Therapy for Patients Presenting With Moderate to Severe Diabetic Ketoacidosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
680
Start Date
2024-03-14
Completion Date
2026-07
Last Updated
2025-09-17
Healthy Volunteers
No
Conditions
Interventions
Plasma-Lyte 148
Plasma-Lyte® 148 intravenous fluid for resuscitation in patients with keto-acidosis
0.9% sodium chloride
0.9% sodium chloride intravenous fluid for resuscitation in patients with keto-acidosis
Locations (21)
Blacktown Hospital
Blacktown, New South Wales, Australia
Camperdown Hospital
Camperdown, New South Wales, Australia
Dubbo Base Hospital
Dubbo, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Maitland Hospital
Metford, New South Wales, Australia
Orange Hospital
Orange, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Caboolture Hospital
Caboolture, Queensland, Australia
Queen Elizabeth II Jubilee Hospital
Coopers Plains, Queensland, Australia
Redcliffe Hospital
Redcliffe, Queensland, Australia
Rockhampton Hospital
Rockhampton, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Ballarat Base Hospital
Ballarat, Victoria, Australia
Monash Health-Casey Hospital
Berwick, Victoria, Australia
Dandenong Hospital
Dandenong, Victoria, Australia
Frankston Hospital - Peninsula Health
Frankston, Victoria, Australia
Latrobe Regional Hospital
Traralgon, Victoria, Australia