A randomised controlled trial of plasmalyte versus normal saline as resuscitation and maintenance fluid therapy for patients presenting with diabetic ketoacidosis (BEST-DKA) BalancEd fluids vs Saline Trial in Diabetic KetoAcidosis
Grant ID: EMPJ-271R39-2023-KEIJZERS
Project Summary
We propose to conduct a multi-centre blinded cluster cross over randomised clinical trial (RCT) of plasmalyte (PL), a balanced salt solution versus normal saline (NS) in patients admitted to an Intensive Care Unit (ICU) with diabetic ketoacidosis (DKA), a life-threatening complication of diabetes mellitus. DKA results in elevated acid levels in the blood leading to severe dehydration and electrolyte imbalance.
ICU admission rates for patients with DKA in Australia has risen annually. In 2019 and 2020, there were 2751 and 2812 admissions to ICUs respectively. Almost all patients present through the Emergency Departments and in regional hospitals, they are often admitted to the ICU.
NS is often used as the first line fluid for dehydration, but NS use frequently results in persistent acidosis. We have shown in a pilot trial, conducted in 7 Queensland regional Emergency departments and ICUs, that the use of a balanced salt solution such as PL resulted in a more rapid resolution of acidosis with trends to shorter length of ICU and hospital stay as compared to NS. The efficacy of PL in DKA needs evaluation in a large clinical trial.
We plan to study 480 patients from Australia of whom a third will be expected to be enrolled in Queensland. Patients will be randomised to receive either NS or PL and the primary end point is hospital length of stay. This proposed trial will answer a fundamental clinical question and will inform policy and practice in Australia and New Zealand and around the world.
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