Protocol for a randomised open-label parallel group multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

摘要

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.