This post-marketing study is undertaken to compare the clinical effectiveness and safety of two continuous ambulatory peritoneal dialysis produced by Fresenius Medical Care (FMC), i.e. Stay Safe® (STS) that is produced by a plant in Germany and Stay Safe Link® (SSL) that is produced in Malaysia. The study is an open labelled, randomised controlled trial where 434 patients in total will be randomised to either STS or SSL in a 1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
472
CAPD system produced in Malaysia by Fresenius Medical Care
CAPD system produce in Germany by Fresenius Medical Care
Clinical Research Centre, Penang Hospital
George Town, Pulau Pinang, Malaysia
Peritonitis Rate of Stay Safe Link system
Time frame: 1 year
Dialysis dose delivered
weekly Kt/V
Time frame: 1 year
Dialysis dose delivered
creatinine clearance (L)
Time frame: 1 year
Ultrafiltration volume
Post-PD bodyweight (kg) minus Pre-PD bodyweight (kg)
Time frame: 1 year
Product deficiencies of the PD system
Defect or leakages of PD bags, tubing or organiser (number of defects or leakages detected)
Time frame: 1 year
Product deficiencies of the PD system
Bacterial or other contamination of dialysate or any component of the PD system (number of contamination detected)
Time frame: 1 year
Safety Assessment of the PD system
Technique failure, defined as the transfer to hemodialysis for more than 30 days (number of technique failure detected)
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.