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Compares treatment options for Diabetic Ketoacidosis
Official title Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
ClinicalTrials.gov ID: NCT05752279
What this study is testing
What is Plasma-Lyte 148?
Plasma-Lyte 148 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diabetic ketoacidosis.
Also referred to as Balanced multi-electrolyte solution.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Blacktown, New South Wales, Australia
- Camperdown, New South Wales, Australia
- Dubbo, New South Wales, Australia
- Kogarah, New South Wales, Australia
- Metford, New South Wales, Australia
- Orange, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Westmead, New South Wales, Australia
- Birtinya, Queensland, Australia
- Caboolture, Queensland, Australia
- Coopers Plains, Queensland, Australia
- Redcliffe, Queensland, Australia
- Rockhampton, Queensland, Australia
- Southport, Queensland, Australia
- Elizabeth Vale, South Australia, Australia
- Woodville South, South Australia, Australia
- Ballarat, Victoria, Australia
- Berwick, Victoria, Australia
- Dandenong, Victoria, Australia
- Frankston, Victoria, Australia
+ 1 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Blacktown, New South Wales, Australia; Camperdown, New South Wales, Australia; Dubbo, New South Wales, Australia; Kogarah, New South Wales, Australia; Metford, New South Wales, Australia; Orange, New South Wales, Australia and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.