ESRD - End Stage Renal Disease Urological and Genital Diseases Renal Disease
Conditions
Interventions
Tested products: twist extension line combined with twist female connector on Gambrosol trio.
Reference products: current patient line (PDL 1201-8) and current Gambro CAPD system.
All patients will
Sponsors
Gambro (Sweden)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients suffering from chronic renal failure 2. Age 18 years or older 3. Treated in a Continuous Ambulatory Peritoneal Dialysis (CAPD) program with Gambrosol trio (GEM 20U03 Ca 2,5) 4. Treated on CAPD for at least 24 months 5. Signed written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. HIV 3. Hepatitis 4. Participation in other studies during the study period if considered to cause interference with either of the studies 5. Treated in a haemodialysis program, patients with diagnosed abdominal pain not related with PD solution 6. Patients on night Automated Peritoneal Dialysis (APD) 7. Peritonitis within one month prior to the study 8. Presence of exit-site/tunnel infection or ongoing peritonitis 9. Impaired and /or disabled patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient satisfaction on handling by comparing current system with new system, twist. | — |
Secondary
| Measure | Time frame |
|---|---|
| Collect safety data on new patient line. | — |
Countries
Italy
Outcome results
None listed