Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

Recruiting now · Phase 3

Conditions studied: Diabetic Ketoacidosis

In brief

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).

Key facts

Study ID

NCT05752279

Run by

The George Institute

People needed

680

Starts

2024-03-14

Expected to finish

2026-07-01

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Blacktown Hospital — Blacktown, New South Wales, Australia (enrolling)
• Camperdown Hospital — Camperdown, New South Wales, Australia (enrolling)
• Dubbo Base Hospital — Dubbo, New South Wales, Australia (enrolling)
• St George Hospital — Kogarah, New South Wales, Australia (enrolling)
• Maitland Hospital — Metford, New South Wales, Australia (enrolling)
• Orange Hospital — Orange, New South Wales, Australia (enrolling)
• Royal North Shore Hospital — St Leonards, New South Wales, Australia (enrolling)
• Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
• Sunshine Coast University Hospital — Birtinya, Queensland, Australia (enrolling)
• Caboolture Hospital — Caboolture, Queensland, Australia (enrolling)
• Queen Elizabeth II Jubilee Hospital — Coopers Plains, Queensland, Australia (enrolling)
• Redcliffe Hospital — Redcliffe, Queensland, Australia (enrolling)
• Rockhampton Hospital — Rockhampton, Queensland, Australia (enrolling)
• Gold Coast University Hospital — Southport, Queensland, Australia (enrolling)
• Lyell McEwin Hospital — Elizabeth Vale, South Australia, Australia (enrolling)
• The Queen Elizabeth Hospital — Woodville South, South Australia, Australia (enrolling)
• Ballarat Base Hospital — Ballarat, Victoria, Australia (enrolling)
• Monash Health-Casey Hospital — Berwick, Victoria, Australia (enrolling)
• Dandenong Hospital — Dandenong, Victoria, Australia (enrolling)
• Frankston Hospital - Peninsula Health — Frankston, Victoria, Australia (enrolling)
• Latrobe Regional Hospital — Traralgon, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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