Rockhampton City

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.

Each year, over 7,000 Australians suffer severe trauma that can cause serious bleeding and poor outcomes. This trauma can disrupt the body's ability to form blood clots, leading to excessive bleeding. Early replacement of clotting factors, especially fibrinogen which helps bind clots together, may improve recovery. This trial, called FEISTY II, is a phase III study comparing two methods of fibrinogen replacement in adults with major trauma and bleeding. The study compares fibrinogen concentrate, a dry powder that can be quickly reconstituted and given at the bedside, with cryoprecipitate, a blood product that requires thawing before use and is harder to supply, especially in remote areas. Participants will receive either 3 grams of fibrinogen concentrate or standard doses of cryoprecipitate (10 units whole blood or 4 units apheresis). This approach aims to evaluate the effectiveness, safety, and cost of these treatments in managing severe bleeding after trauma. Participants will be adults with trauma who are actively bleeding and require emergency blood transfusions. Researchers will monitor the number of days participants are alive and out of the hospital within 90 days after injury. The study will also assess safety and resource use. A total of 850 patients will be enrolled from major trauma centers in Australia and New Zealand, with follow-up to 90 days post-injury.

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 the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

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.

Researchers are evaluating the effects of two monoclonal antibodies, tiragolumab and atezolizumab, in adults with locally advanced or metastatic solid tumors that cannot be removed by surgery or have spread. These tumors have specific characteristics that may predict how well the immune system responds to treatment. The study focuses on blocking immune receptors PD-L1 and TIGIT, which cancers use to evade immune attack, aiming to reactivate the body's anti-tumor response. This is a phase II trial involving patients identified through cancer screening programs who meet specific tumor marker criteria. Participants first undergo a 21-day screening to confirm eligibility. Tiragolumab is given alone on the first day of treatment, followed by combined tiragolumab and atezolizumab every 21 days starting from the second treatment cycle. A tumor biopsy is performed at Week 4 before beginning atezolizumab treatment. Standard imaging scans like CT are done regularly during the trial. Blood, urine, and stool samples are also collected throughout the study. After treatment ends, participants have a study visit within 30 days. If treatment stops before disease progression, follow-up calls occur every 9 weeks until progression. Once progression happens, study visits take place every 3 months for up to a year after the last participant stops treatment. Active follow-up continues until death or 12 months after treatment ends, with survival data collected thereafter. The main outcome measured is progression-free survival at 6 months.