Coopers Plains

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.

Researchers are evaluating the long-term effects of lidocaine infusions given during and after surgery on the development of moderate or severe chronic post-surgical pain (CPSP) one year after breast cancer surgery in adult female patients. This Phase 3, international, randomized, double-blind, placebo-controlled trial involves more than 4,000 participants undergoing mastectomy or breast conserving surgery. The study aims to detect a 25% reduction in CPSP incidence and also assesses safety, pain relief effectiveness, neuropathic pain characteristics, psychological well-being, and quality of life. Participants receive either a lidocaine infusion or a placebo infusion starting with an intravenous bolus after anesthesia induction, followed by continuous intravenous infusion during surgery. After surgery, a subcutaneous lidocaine or placebo infusion is continued for up to 24 hours. Dosages are based on lean body weight and capped at 68 kg. Patients undergoing day-case surgery receive only the intraoperative bolus and infusion without the postoperative infusion. Throughout the study, patient pain levels, opioid use, safety events, neuropathic pain symptoms, psychological status, and quality of life are closely monitored. The primary outcome is the patient-reported incidence of moderate or severe CPSP one year after surgery. Data collection includes follow-up visits and assessments to track both short-term and long-term effects of the treatments.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.