Extrait

This pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline) with aseptic technique in prevention of PD-related infection. It is a pilot study, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths in a ratio of 1:1:1. They will be followed at 1,3,6,9, and 12 months or until PD-related infection, catheter removal, or death. The primary outcome is PD-related infection. Secondary outcomes are safety, adverse events related to treatments such as skin irritation, rash etc. Other outcomes are hospitalization due to PD-related infection, technical failure,change of modal of dialysis, adherence to medication, death due to PD-related infection. Costs include providers and patients expenses. Utility is assessed using the EuroQol (EQ), five-dimensional (5D), five-level (5L) version. The results of this study are anticipate nephrologists and health care professional involving to PD in decision making for a plan to prevent PD-related infection. In addition, the results will lead to clinical guideline development a prevention of PD-related infection.

Critère d'inclusion

• End stage renal disease,Peritoneal dialysis

Liens

• ictrp
• nct