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

Quick facts

Principal investigator:

Prof Gerben Keijzers

Team members:

Dr Mahesh Ramanan
Ms Stacey Watts
Dr Jason Chan
Dr Kent Perkins
Ms Lauren Murray
Dr Benjamin Moran
A/Prof Naomi Hammond
Prof Balasubramanian Venkatesh

Associate Investigators

A/Prof Alisa Higgins
Ms Dorrilyn Rajbhandari
Dr Antony Attokaran
Dr Thomas Holland
Prof Elif Ekinci
Dr David Stewart
Dr James McCullough

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.

Grants Awarded

Emergency Medicine Foundation
$164,384
MRFF
$1,655,323

Mandatory research projects during medical specialist training in Australia and New Zealand: a survey of trainees’ experiences and reports

Stehlik P, Withers C, Bourke RC, Barnett AG, Brandenburg C, Noble C, Bannach‐Brown A, Keijzers GB, Scott IA, Glasziou PP, Veysey EC. Mandatory research projects during medical specialist training in Australia and New Zealand: a survey of trainees’ experiences and reports. Medical Journal of Australia. 2025.
 

Diagnostic accuracy of a machine learning algorithm using point-of-care high-sensitivity cardiac troponin I for rapid rule-out of myocardial infarction: a retrospective study.

Toprak, B., Solleder, H., Di Carluccio, E., Greenslade, J.H., Parsonage, W.A., Schulz, K., Cullen, L., Apple, F.S., Ziegler, A., Blankenberg, S., Keijzers, G., Hall, E. J., Stephensen, L., on behalf of the ARTEMIS group., 2024. Diagnostic accuracy of a machine learning algorithm using point-of-care high-sensitivity cardiac troponin I for rapid rule-out of myocardial infarction: a retrospective study. The Lancet Digital Health, 6(10), pp.e729-e738.

Minimal intervention (removable splint or bandage) for the management of distal forearm fractures in children and adolescents: A scoping review.

Snelling, P.J., Goodwin, P., Clark, J., Bade, D., Bindra, R., Ware, R.S. and Keijzers, G., 2024. Minimal intervention (removable splint or bandage) for the management of distal forearm fractures in children and adolescents: A scoping review. Injury, p.111897.

OPTimising MEDicine information handover after Discharge (OPTMED-D): protocol for development of a multifaceted intervention and stepped wedge cluster randomised controlled trial. 

Hattingh, L., Baysari, M.T., Foot, H., Sim, T.F., Keijzers, G., Morgan, M., Scott, I., Norman, R., Yong, F., Mullan, B., Jackson, C., Oldfield, L. E. and Manias, E., 2024. OPTimising MEDicine information handover after Discharge (OPTMED-D): protocol for development of a multifaceted intervention and stepped wedge cluster randomised controlled trial. Trials, 25(1), p.632.

“Luck of the draw really”: a qualitative exploration of Australian trainee doctors’ experiences of mandatory research.

Brandenburg, C., Hilder, J., Noble, C., Liang, R., Forrest, K., Joshi, H., Keijzers, G., Mickan, S., Pearson, D., Scott, I.A. and Veysey, E., 2024. “Luck of the draw really”: a qualitative exploration of Australian trainee doctors’ experiences of mandatory research. BMC Medical Education, 24(1), p.1021.

Evaluating the use of the ABCD2 score as a clinical decision aid in the emergency department: Retrospective observational study

Wahi, S., Michaleff, Z. A., Lomax, P., Brand, A., van der Merwe, M., Jones, M., . . . Keijzers, G. (2023). Evaluating the use of the ABCD2 score as a clinical decision aid in the emergency department: Retrospective observational study. Emerg Med Australas. 

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