Colatina

Septic shock is a serious condition marked by low blood pressure, reduced resistance in blood vessels, and poor response to drugs that constrict blood vessels, with nitric oxide playing a key role in this problem. Research shows that reduced response to certain medications is linked to changes in specific receptors and increased levels of a protein called GRK2, which nitric oxide helps raise. This study explores the idea that heart and blood vessel problems in sepsis may be caused by higher GRK2 activity, and that blocking this protein could be an effective treatment. The trial is evaluating paroxetine, given at a dose of 40 mg once daily for five days or until 24 hours after the shock resolves. Participants with septic shock will receive this medication or a placebo in a randomized, controlled setting to assess its effects on cardiovascular function. The study is a Phase 2 clinical trial designed to test whether paroxetine can regulate GRK2 expression and improve outcomes in septic shock. Participants will be followed for up to 28 days after enrollment, with the main measurement being the time until vasopressor medications can be stopped. Researchers will monitor heart and blood vessel function, drug usage, and overall health during this period. The study includes careful observation of safety and effectiveness to better understand paroxetine's potential role in treating septic shock.

This research aims to collect real world data on patient characteristics, disease management, healthcare use, and outcomes for people living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It focuses on understanding how these conditions are managed and the quality of care patients receive in everyday clinical practice across many countries. The registry is observational and voluntary, designed to fill gaps in knowledge about these diseases globally. The study uses a multinational, observational registry with a cloud-based electronic case report form (eCRF) to gather both prospective and retrospective data. This system is accessible to doctors managing patients with type 2 diabetes, hypertension, heart failure, or chronic kidney disease worldwide. There are no specific treatments or interventions given as part of this study since it is a data collection registry. Participants provide information for an average of 3 years during the study. Researchers will collect data on patient characteristics, disease management, healthcare use, quality of care indicators, cardiovascular outcomes, kidney outcomes, and other related complications. The registry allows ongoing data entry and monitoring to better understand real world outcomes and care quality for these conditions.

Researchers are investigating whether an educational quality improvement intervention can reduce the use of antimicrobials in adult patients admitted to intensive care units (ICUs) in Brazil. This trial focuses on critically ill patients and aims to see if training ICU doctors and healthcare professionals to follow updated guidelines can decrease antimicrobial consumption without negatively impacting ICU mortality rates or length of stay. The study is designed as a stepped-wedge cluster randomized trial involving 10 ICUs participating in a larger registry focused on ICU infections and antimicrobial use. The intervention includes educational sessions, an operations manual, and cognitive aids to help ICU physicians make better decisions about starting, reviewing, and stopping antimicrobials based on current recommendations. Each ICU will receive an initial site visit to deliver training and assess local barriers to implementation. Following this, monthly one-day audits will be performed to monitor antimicrobial use and provide feedback to the ICU teams. The study includes a baseline period before the intervention, a phased implementation over 10 steps starting in July 2025, and a three-month phase-out period to observe if benefits persist after active feedback stops. Participants will be adult patients admitted to the ICUs during the study period. Data collection includes monthly point-prevalence surveys of antimicrobial use and routine information from the existing ICU registry. Researchers will evaluate antimicrobial utilization at the ICU level over 14 months, monitoring safety outcomes such as ICU mortality and length of stay. The total participation for each ICU spans from baseline through intervention and phase-out periods, with ongoing data analysis to assess the intervention's impact.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.