Colatina

Septic shock is a serious condition marked by low blood pressure, reduced resistance in blood vessels, and poor response to drugs that tighten blood vessels. This condition involves nitric oxide affecting organ function, and researchers believe that changes in certain heart and blood vessel receptors, along with increased GRK2 enzyme activity, contribute to these problems. The study explores whether blocking GRK2 activity with paroxetine might improve heart and blood vessel function in patients with septic shock. Participants will be randomly assigned to receive either paroxetine or a placebo. Paroxetine is given as a 40 mg dose once daily by mouth or through an enteric tube for up to five days or until the shock resolves. The study is designed as a randomized, placebo-controlled trial with quadruple masking to evaluate the effects of paroxetine on cardiovascular function during septic shock. During the study, researchers will monitor how long it takes for patients to stop needing vasopressor drugs over 28 days. They will also track the total doses of vasopressors used in the first two and five days, changes in organ failure scores related to the heart and circulation, length of stay in the intensive care unit, and mortality during ICU stay. Patients will be closely assessed for these outcomes to understand paroxetines impact on septic shock recovery.

This research aims to collect real-world data on the characteristics, management, healthcare use, and outcomes of patients living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It is an international observational registry that includes patients from many countries to better understand how these conditions are treated in everyday clinical practice. Participants in this registry are observed without receiving experimental treatments. Data are collected both retrospectively and prospectively using a cloud-based electronic case report form accessible to investigators and a scientific committee. The registry includes groups of patients with type 2 diabetes, hypertension, chronic kidney disease, or heart failure, either as their primary condition or as a coexisting condition. Patients provide information about their health status, treatments, and outcomes over time. Researchers collect data on demographics, disease characteristics, laboratory tests, treatments, healthcare visits, hospitalizations, and lifestyle factors. The study measures many outcomes such as blood sugar levels, kidney function, heart function, medication use, and health events over an average of three years. Participation is voluntary and ongoing, with data collection continuing until the study end date in 2030.

This research aims to evaluate whether an educational quality improvement intervention focused on antimicrobial stewardship can reduce antimicrobial use in adult patients admitted to intensive care units ICUs in Brazil. The study compares current ICU practices with those after implementing the intervention, which is based on up-to-date guidelines and aims to promote rational antimicrobial use without increasing ICU mortality or length of stay. The trial uses a stepped-wedge cluster randomized design across 10 ICUs participating in the IMPACTO-MR registry platform. The intervention includes educational sessions, cognitive aids for ICU physicians and healthcare professionals to improve decisions on antimicrobial initiation and duration, and monthly audits with feedback to the ICU teams. Each ICU starts with a control phase of usual care, then transitions to the intervention phase approximately monthly starting July 2025. The study also includes a baseline data collection period before the intervention and a phase-out period to assess lasting effects after stopping feedback. Participants are all adult patients admitted to the participating ICUs during the study. Researchers will collect monthly one-day point-prevalence surveys on antimicrobial use and monitor ICU mortality rates and length of stay over 14 months to evaluate outcomes. The study will assess the impact of the educational intervention on antimicrobial use while ensuring patient safety, with no individual informed consent required due to cluster-level data collection and minimal risk.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.