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Actively Recruiting

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.

Age: 18Years +All GendersPhase 4
264 locations
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Actively Recruiting

Researchers are investigating the management of complex renal cysts, specifically Bosniak III and IV cysts, which are common in individuals over 60 years old. These cysts vary in their risk of being cancerous, and while surgery has traditionally been recommended, evidence suggests many cysts are benign or have low potential to spread. This study aims to compare the 5-year cancer-specific survival between patients managed by active surveillance and those undergoing surgery to better understand the safety and outcomes of monitoring these cysts without immediate surgery. The study is a multicenter prospective observational cohort involving patients who choose either surgery or active surveillance. Those in the active surveillance group receive imaging and blood tests every six months for the first three years, then annually afterward. The surgery group undergoes partial or full kidney removal followed by annual imaging. Patients are followed according to standard care with visits scheduled semi-annually or annually, depending on their management choice. Participants will be monitored over five years with regular assessments including quality of life questionnaires and evaluations for disease progression. Those under active surveillance will be checked closely for cyst changes and may receive additional treatments if progression occurs. The main outcome measured is the 5-year cancer-specific survival, along with evaluations of disease progression, patient well-being, and healthcare costs related to each management strategy.

Age: 18Years +All Genders
18 locations
Medical trials in Woodstock, IL | Decentrialz