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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stay Safe (STS) | Active Comparator | CAPD system produced by Fresenius Medical Care in Germany |
|
| Stay Safe Link (SSL) | Experimental | CAPD system produced by Fresenius Medical Care in Malaysia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stay Safe Link (SSL) | Device | CAPD system produced in Malaysia by Fresenius Medical Care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peritonitis Rate of Stay Safe Link system | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Dialysis dose delivered | weekly Kt/V | 1 year |
| Dialysis dose delivered | creatinine clearance (L) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loke Meng Ong | Clinical Research Centre, Penang General Hospital, Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Centre, Penang Hospital | George Town | Pulau Pinang | 10990 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30852538 | Derived | Mak WY, Ong LM, Goh BL, Bavanandan S, Mushahar L, Leong CT, Hooi LS. 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. BMJ Open. 2019 Mar 8;9(3):e024589. doi: 10.1136/bmjopen-2018-024589. |
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There is no plan to share individual participant data with other researchers
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| Stay Safe (STS) | Device | CAPD system produce in Germany by Fresenius Medical Care |
|
| Ultrafiltration volume | Post-PD bodyweight (kg) minus Pre-PD bodyweight (kg) | 1 year |
| Product deficiencies of the PD system | Defect or leakages of PD bags, tubing or organiser (number of defects or leakages detected) | 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) | 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) | 1 year |