Coopers Plains

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.

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.

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.