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To investigate the biocompatibility of the peritoneal dialysis (PD) solution balance in comparison to the conventional PD solution in APD(automated peritoneal dialysis) patients using the APD cycler sleep•safe.
Equivalence of the investigational PD solution balance regarding fluid status compared to the conventional PD solution.
Effects of balance on inflammation and systemic advanced glycation end products formation.
Effects of balance on peritoneal and total urea clearance, on peritoneal and total creatinine clearance and on ultrafiltration, on residual diuresis and on cholesterol levels.
Safety of the investigational PD solution balance and the conventional PD solution as a control drug.
The mesothelial cell mass assessed by Cancer Antigen 125 is affected by the use of the type of PD solution in APD patients using sleep•safe. Treating patients with the PD solution balance leads to not more than 1 litre difference in hydration in comparison to the conventional PD solution which is considered as clinically not relevant regarding blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solution B (balance PD solution) | Experimental | Treatment 8 weeks with solution B (balance PD solution), next 8 weeks with solution A (conventional PD solution) |
|
| Solution A (conventional PD solution) | Active Comparator | Treatment 8 weeks with solution A (conventional PD solution), next 8 weeks with solution B (balance PD solution) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solution B (balance PD solution) | Drug | balance 1.5% glucose, solution for peritoneal dialysis; balance 2.3% glucose, solution for peritoneal dialysis; balance 4.25% glucose, solution for peritoneal dialysis, each with 1.25 mmol/l or 1.75 mmol/l calcium |
| Measure | Description | Time Frame |
|---|---|---|
| CA 125 (cancer antigen 125) appearance rate in the 24 hours effluent and estimated hydration | The appearance rate is defined as the sum of the amount of CA125 determined in each outflow bag (concentration of CA125 in outflow multiplied with outflow volume) divided by the real cumulative dwell time of all dwells performed on the day of the 24-hour dialysate collection. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariano Feriani, MD | Ospedale Umberto Oo, 30174 Mestre, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centrum Dializ Fresenius Nephrocare | Gdansk | Poland | ||||
| Uniwersytecki Szpital Kliniczny nr 1 |
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| Solution A (conventional PD solution) | Drug | Solutions for peritoneal dialysis: CAPD 2 (1.5% glucose, 1.75mmmol/l calcium), CAPD 3 (4.25 % glucose, 1.75mmmol/l calcium), CAPD 4 (2.3% glucose, 1.75mmmol/l calcium), CAPD 17 (1.5% glucose, 1.25mmmol/l calcium), CAPD 18 (4.25% glucose, 1.25mmmol/l calcium) and CAPD 19 (2.3% glucose, 1.25mmmol/l calcium) |
|
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| Lodz |
| Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie | Lublin | Poland |
| Complejo hospitalario universitario de Albacete | Albacete | Spain |
| Fundación Hospital Alcorcón | Madrid | Spain |
| Hospital Universitario Puerta de Hierro | Madrid | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Spain |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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