Rockhampton City

This trial investigates whether fluid therapy with Plasma-Lyte48 increases the number of days alive and out of hospital by day 28 compared to 0.9% sodium chloride saline in critically ill patients with moderate to severe diabetic ketoacidosis DKA admitted to emergency departments and critical care units. DKA is a serious complication of diabetes, and hospital admissions for this condition have risen notably in recent years. Current treatment guidelines rely on limited evidence, creating a need for clearer information on the best fluid therapy approach. Participants receive either Plasma-Lyte48 or 0.9% saline as intravenous fluids for resuscitation during two 12-month periods across 20 hospitals, with a one-month break between periods. Each hospital switches fluids after the first period. The fluids are blinded and provided by Baxter Healthcare, with treatments continuing until discharge from critical care or up to 72 hours. Additional therapies, including glucose solutions and electrolyte supplements, are used as needed based on clinical judgment. During the study, patients are monitored for hospital-free days up to 28 days after enrollment, with telephone follow-up to collect information. Secondary outcomes include ICU-free days, readmissions, kidney function, mental status changes, ketosis resolution time, insulin use, and potassium replacement. The study involves consumer representatives and aims to provide evidence to improve DKA management. Total participation involves treatment and follow-up over 28 days post-enrollment.

Severe trauma can cause heavy bleeding and changes in blood clotting that make it hard for injured patients to stop bleeding effectively. This trial focuses on adults with severe trauma who experience low fibrinogen levels, a key clotting factor, to compare two ways of replacing fibrinogen during major bleeding. The study aims to evaluate the safety, effectiveness, and cost of fibrinogen concentrate versus cryoprecipitate, which is the current standard treatment made from donated blood. Participants will be randomly assigned to one of two groups one will receive fibrinogen concentrate, a dry powder that can be quickly prepared and given at the bedside, and the other will receive cryoprecipitate, which requires thawing before use and contains multiple clotting factors. Dosing is guided by specific clotting tests measuring fibrinogen levels. The study includes 850 patients from trauma centers in Australia and New Zealand and follows them for outcomes after treatment. During the study, researchers will monitor participants days alive and out of hospital up to 90 days after injury, along with other measures like blood transfusion amounts, mortality rates, organ failure, and quality of life over 12 months. Safety is assessed by tracking blood clot-related events and other complications. This phase III randomized trial uses blinded methods to ensure reliable results and includes careful follow-up to understand the impact of fibrinogen replacement in traumatic bleeding.

Researchers are evaluating the long-term effects of lidocaine infusions given during and after surgery to reduce moderate or severe chronic post-surgical pain in adult women undergoing elective breast cancer surgery. This large, international, randomized, double-blind trial aims to detect a meaningful reduction in chronic pain one year after surgery and also assesses safety, pain relief, opioid use, nerve-related pain symptoms, psychological health, and quality of life. Participants receive either a lidocaine infusion starting with an intravenous bolus after anesthesia induction, continuing with an intraoperative intravenous infusion, and followed by a post-operative subcutaneous infusion for up to 24 hours. The lidocaine dosing is adjusted by lean body weight with a cap, while the comparison group receives a saline placebo infusion following the same schedule. Day-case surgeries receive only the intraoperative treatments without the post-operative infusion. During the trial, participants will be monitored for pain severity, opioid consumption, nerve-related symptoms, psychological distress, physical functioning, quality of life, safety events, and health care costs up to one year after surgery. The primary outcome is the incidence of moderate or severe chronic post-surgical pain reported at one year. Assessments include patient-reported outcomes, pain scores at 24 hours postoperatively, and opioid use at various timepoints. The total participation duration extends up to one year after surgery.

This research aims to evaluate the effects of combining baxdrostat 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 a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Researchers are evaluating the effects of two monoclonal antibodies, tiragolumab and atezolizumab, in patients with locally advanced or metastatic solid cancers that cannot be removed by surgery or have spread. These cancers have specific characteristics that may predict how well they respond to immune-based treatments. The study focuses on blocking immune receptors PD-L1 and TIGIT, which tumors use to avoid attack by the immune system, with the goal of reactivating the bodys ability to fight the cancer. Patients who have been screened through specific cancer programs and whose tumors fit the study criteria will join after a 21-day screening period. At the start, patients receive tiragolumab alone, followed by combined tiragolumab and atezolizumab every 21 days. Treatment continues in cycles until it is stopped, with biopsies and imaging done to monitor tumor response. Participants are divided into subgroups based on tumor mutation burden, PD-L1 expression, gene amplification, or tumor-infiltrating lymphocytes. Throughout the study, participants will have biopsies, CT scans, and samples of blood, urine, and stool collected. Follow-up visits and calls will continue after treatment ends to track disease progression and survival for up to 12 months or until death. Researchers will assess progression-free survival at 6 months as the primary outcome, along with tumor response, overall survival, quality of life, and safety measures throughout the study period.