Plasma-Lyte 148 versus saline for treating moderate to severe diabetic ketoacidosis
Balanced Multi-electrolyte Solution Versus 0.9% Sodium Chloride as Fluid Therapy for Patients Presenting With Moderate to Severe Diabetic Ketoacidosis
This trial tests whether giving Plasma-Lyte 148 instead of standard saline helps adults with moderate to severe diabetic ketoacidosis be alive and out of the hospital for more days by day 28.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 680 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The George Institute Academic / other |
| Locations | 21 sites (Blacktown, New South Wales and 20 other locations) |
| Trial ID | NCT05752279 on ClinicalTrials.gov |
What this trial studies
This is a blinded, cluster cross-over, randomized controlled Phase 3 trial comparing Plasma-Lyte 148 to 0.9% sodium chloride for initial fluid therapy in adults presenting to the emergency department with moderate to severe diabetic ketoacidosis who require admission to a critical care area. Patients meeting biochemical criteria for DKA (blood glucose >14 mmol/L, pH <7.25, bicarbonate <15 mmol/L, elevated anion gap, positive ketones) are enrolled and receive whichever study fluid is assigned for their cluster period. The primary outcome is days alive and out of hospital to day 28, with secondary outcomes including resolution of acidosis and usual safety measures. The trial is conducted at several New South Wales hospitals and is designed to provide definitive phase 3 evidence on fluid choice in DKA.
Who should consider this trial
Good fit: Adults in the ED with moderate to severe DKA who need admission to an ICU or high-dependency unit and meet biochemical criteria (glucose >14 mmol/L, pH <7.25, bicarbonate <15 mmol/L, elevated anion gap, positive ketones) are ideal candidates.
Not a fit: People under 18, those with hyperosmolar hyperglycaemic non-ketotic syndrome, major sodium abnormalities, a contraindication to either fluid, or who have already received >2000 mL of non-study fluid before enrolment are unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, using Plasma-Lyte 148 could shorten recovery from acidosis and increase the number of days patients are alive and out of the hospital within 28 days.
How similar studies have performed: Smaller studies in DKA have suggested Plasma-Lyte may lead to faster acidosis resolution with similar glucose control, but definitive large randomized phase 3 evidence has been limited.
Eligibility criteria
Show full inclusion / exclusion 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 \<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 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 \<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 this trial is running
Blacktown, New South Wales and 20 other locations
- Blacktown Hospital — Blacktown, New South Wales, Australia (Recruiting)
- Camperdown Hospital — Camperdown, New South Wales, Australia (Recruiting)
- Dubbo Base Hospital — Dubbo, New South Wales, Australia (Recruiting)
- St George Hospital — Kogarah, New South Wales, Australia (Recruiting)
- Maitland Hospital — Metford, New South Wales, Australia (Recruiting)
- Orange Hospital — Orange, New South Wales, Australia (Recruiting)
- Royal North Shore Hospital — St Leonards, New South Wales, Australia (Recruiting)
- Westmead Hospital — Westmead, New South Wales, Australia (Recruiting)
- Sunshine Coast University Hospital — Birtinya, Queensland, Australia (Recruiting)
- Caboolture Hospital — Caboolture, Queensland, Australia (Recruiting)
- Queen Elizabeth II Jubilee Hospital — Coopers Plains, Queensland, Australia (Recruiting)
- Redcliffe Hospital — Redcliffe, Queensland, Australia (Recruiting)
- Rockhampton Hospital — Rockhampton, Queensland, Australia (Recruiting)
- Gold Coast University Hospital — Southport, Queensland, Australia (Recruiting)
- Lyell McEwin Hospital — Elizabeth Vale, South Australia, Australia (Recruiting)
- The Queen Elizabeth Hospital — Woodville South, South Australia, Australia (Recruiting)
- Ballarat Base Hospital — Ballarat, Victoria, Australia (Recruiting)
- Monash Health-Casey Hospital — Berwick, Victoria, Australia (Recruiting)
- Dandenong Hospital — Dandenong, Victoria, Australia (Recruiting)
- Frankston Hospital - Peninsula Health — Frankston, Victoria, Australia (Recruiting)
- Latrobe Regional Hospital — Traralgon, Victoria, Australia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.