Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
Recruiting
Phase 3
Interventional Study
Diabetic Ketoacidosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 680 (estimated)
- Sponsor
- The George Institute · Other
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About This Trial
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 mode…
Trial Locations
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Eligibility 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 o…
Contacts
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