Metford

Researchers are evaluating whether fluid therapy using Plasma-Lyte48 compared to 0.9% sodium chloride can increase the number of days alive and days out of hospital by day 28 for critically ill patients with moderate to severe diabetic ketoacidosis (DKA) admitted to emergency departments and critical care areas. This phase 3, blinded, cluster crossover randomized controlled trial addresses the rising incidence and hospital admissions for DKA, aiming to provide definitive evidence to guide optimal fluid resuscitation. The study responds to current gaps in evidence and variability in DKA management protocols across hospitals in Australia. The trial involves 20 Australian hospitals participating in two 12-month intervention periods separated by a one-month gap. Each hospital uses either Plasma-Lyte48 or 0.9% saline as the blinded fluid therapy during the first period, then switches to the alternate fluid in the second period. Both fluids are supplied and labeled to preserve blinding, and clinicians administer the fluids based on standard clinical endpoints for up to 72 hours or until discharge from critical care. Additional treatments like glucose-containing solutions, bicarbonate, and electrolyte supplements are given as needed under clinician discretion. Participants will be monitored through the critical care stay and contacted by telephone at day 28 to assess outcomes. The main measurement is hospital-free days within 28 days after enrollment. The study also involves end-user representatives in all stages, ensuring consumer perspectives in protocol design and dissemination. This comprehensive approach aims to clarify the best fluid treatment for moderate to severe DKA and improve patient care and health outcomes.