Continuous Ambulatory Peritoneal Dialysis
Conditions
Brief summary
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.
Interventions
DEVICEStay Safe Link (SSL)
CAPD system produced in Malaysia by Fresenius Medical Care
DEVICEStay Safe (STS)
CAPD system produce in Germany by Fresenius Medical Care
Sponsors
Penang Hospital, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or above 2. End stage kidney failure receiving Stay Safe® PD system for at least 4 weeks 3. Written informed consent
Exclusion criteria
1. Requirement for 2.5L exchanges 2. Requirement for Stay Safe Balance® 3. PD-related infection (peritonitis, exit site or tunnel tract infection) in the preceding 8 weeks or during conversion 4. Malfunctioning of PD catheter 5. Planned transfer to automated peritoneal dialysis, haemodialysis or transplant within 90 days 6. Pregnancy 7. Any condition that compromises the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity, such as documented loss of peritoneal function 8. History of active alcohol or substance abuse in the previous 6 months 9. Other medical condition which, in the investigator's judgement, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peritonitis Rate of Stay Safe Link system | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis dose delivered | 1 year | weekly Kt/V |
| Ultrafiltration volume | 1 year | Post-PD bodyweight (kg) minus Pre-PD bodyweight (kg) |
| Product deficiencies of the PD system | 1 year | Defect or leakages of PD bags, tubing or organiser (number of defects or leakages detected) |
| Safety Assessment of the PD system | 1 year | Technique failure, defined as the transfer to hemodialysis for more than 30 days (number of technique failure detected) |
Countries
Malaysia
Outcome results
None listed