Actively Recruiting
Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
Led by The George Institute · Updated on 2025-09-17
680
Participants Needed
21
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients in the emergency department with a primary diagnosis of moderate to severe diabetic ketoacidosis
- Both saline and Plasma-Lyte48 are considered suitable fluids for treatment
- Blood glucose level greater than 14 mmol/L
- Blood pH less than 7.25
- Serum bicarbonate less than 15 mmol/L
- Elevated anion gap greater than 12 mEq/L
- Positive ketones on finger prick test
- Treating clinician judges admission to critical care area is required
You will not qualify if you...
- Age less than 18 years
- Received more than 2000 ml of non-study fluid before enrollment
- Serum sodium level greater than 155 mmol/L or less than 120 mmol/L
- Contraindication to study fluids such as previous allergic reaction to Plasma-Lyte48
- Diagnosis of hyperosmotic hyperglycaemic non-ketotic syndrome
- Other clinical conditions preventing large volume fluid resuscitation
- Previous participation in this BEST-DKA trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
2
Camperdown Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
3
Dubbo Base Hospital
Dubbo, New South Wales, Australia, 2830
Actively Recruiting
4
St George Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
5
Maitland Hospital
Metford, New South Wales, Australia, 2323
Actively Recruiting
6
Orange Hospital
Orange, New South Wales, Australia, 2800
Actively Recruiting
7
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
8
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
9
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Actively Recruiting
10
Caboolture Hospital
Caboolture, Queensland, Australia
Actively Recruiting
11
Queen Elizabeth II Jubilee Hospital
Coopers Plains, Queensland, Australia, 4108
Actively Recruiting
12
Redcliffe Hospital
Redcliffe, Queensland, Australia, 4020
Actively Recruiting
13
Rockhampton Hospital
Rockhampton, Queensland, Australia, 4700
Actively Recruiting
14
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
15
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Actively Recruiting
16
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Actively Recruiting
17
Ballarat Base Hospital
Ballarat, Victoria, Australia, 3350
Actively Recruiting
18
Monash Health-Casey Hospital
Berwick, Victoria, Australia, 3806
Actively Recruiting
19
Dandenong Hospital
Dandenong, Victoria, Australia, 3175
Actively Recruiting
20
Frankston Hospital - Peninsula Health
Frankston, Victoria, Australia, 3199
Actively Recruiting
21
Latrobe Regional Hospital
Traralgon, Victoria, Australia, 3844
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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