Background
A trial to determine whether treatment with Plasmalyte-148 (PL) compared to Normal Saline (NS) results in faster resolution of diabetic ketoacidosis (DKA) and whether the acetate in PL potentiates ketosis.
Design
The proposed study is a cluster cross over trial in participating hospitals in QLD, WA and SA. Hospitals participating in the trial will be initially randomised to either PL or NS for a 6-month period, after which they will change over to the other intervention fluid for another 6-month period.
There will be a 1-month washout period during between the two 6-month intervention blocks.
During the intervention phases all patients with moderate or severe DKA presenting to the
hospital and expected to be admitted to the ICU will be enrolled in the ED or in ICU.
Trial Length & Mackay Base Hospital Recruitment Aims
The trial ran over 12 months with 12 patients being recruited in Mackay.