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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying early recognition tools designed for children under 18 years old with suspected infection to improve sepsis detection in diverse healthcare settings across Asia. This study focuses on evaluating the Phoenix sepsis scores ability to predict mortality risk and developing a new tool called the Sepsis Optimal Recognition Toolkit in children SORT. It also explores how feasible and acceptable it is to use Phoenix criteria in clinical practice and investigates conditions that mimic sepsis in children. The study involves two groups a retrospective cohort of children hospitalized with suspected infection from January 2020 to December 2025, and a prospective cohort from February 2026 to June 2028. Data collected include various clinical measurements within the first 24 hours of hospital admission, such as respiratory, cardiovascular, coagulation, neurological, endocrine, immune, renal, and liver function indicators. These data are used to apply the Phoenix Sepsis Score and develop the SORT tool. Participants contribute data to help evaluate sepsis recognition methods. Researchers link emergency and inpatient records to gather the worst clinical values during the first day of hospital stay. They measure how well the Phoenix score and SORT predict sepsis and mortality over two years. The study also examines the practicality of using the Phoenix criteria and looks into diseases that may mimic sepsis. The study is planned to continue until December 2028.
Actively Recruiting
Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.
Actively Recruiting
Researchers are evaluating the real-world effectiveness and safety of Nebilet4 nebivolol in adults with hypertension across seven Asian countries. This multinational, multicenter, observational, and prospective study aims to assess blood pressure changes, treatment adherence, quality of life, prescription patterns, and cardiovascular outcomes over up to three years. The study also compares Nebilet4 used alone versus in combination therapy and investigates the relationship between home and office blood pressure measurements. Participants include about 5,000 adults newly diagnosed with or having uncontrolled hypertension who have recently started Nebilet4 or been on it no more than two weeks. Patients are followed regularly for 12, 24, and 36 months, with blood pressure measured at each visit and home readings encouraged. The study collects data on medication dosing and frequency, adherence, and cardiovascular risk factors, while monitoring major adverse cardiac events such as heart attack, stroke, and cardiovascular death. During the study, participants complete questionnaires to assess quality of life and medication adherence every few months. Data are recorded through an electronic system ensuring consistency across sites. Researchers evaluate changes in systolic and diastolic blood pressure and the proportion achieving target blood pressure goals. Safety and any adverse events are documented, with follow-up visits extending up to three years to provide insights into the long-term management of hypertension with Nebilet4.
Actively Recruiting
Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.