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Chronic utilization of bio-incompatible peritoneal dialysis (PD) solution has been implicated as a cause of progressive loss of peritoneal permeability and recurrent fluid overload in PD patients. Previous studies show that PD solution with neutral pH and low GDP resulted in a superior profile of PD effluent mesothelial cell marker and a lower degree of systemic inflammation as compared to conventional PD solution. The investigators propose a prospective randomized control study to compare the arterial stiffness, nutrition and body fluid status between PD patients treated with conventional solution and those with neutral pH low GDP solution. The investigators plan to study 100 new PD patients. They will be randomized to be treated with neutral pH low GDP solution or conventional solution. All patients will be followed for 52 weeks. In addition to routine clinical measurements, the investigators will measure their body water composition by bioimpedance spectroscopic method, arterial pulse wave velocity by pressure transduction method, as well as radiographic parameters of intravascular volume status, based on the routine chest radiograph. The study would help to define the clinical benefit of biocompatible PD solution.
(see above)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balance group | Experimental | peritoneal dialysis with neutral peritoneal dialysis solution with minimal glucose-degradation-product |
|
| Control group | Active Comparator | conventional PD solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| double-chamber bag Stay-Safe Balance system | Other | 2-L exchange; three times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| body composition | 52 weeks | |
| arterial pulse wave velocity | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| nutritional and adequacy indices | 52 weeks | |
| peritoneal transport characteristics | 52 weeks | |
| residual renal function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheuk Chun Szeto, MD | Chinese University of Hong Kong | Principal Investigator |
| Philip KT Li, MD | Prince of Wales Hospital, Shatin, Hong Kong | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine & Therapeutics, Prince of Wales Hospital | Shatin | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26510186 | Derived | Szeto CC, Kwan BC, Chow KM, Cheng PM, Kwong VW, Choy AS, Law MC, Leung CB, Li PK. The Effect of Neutral Peritoneal Dialysis Solution with Low Glucose-Degradation-Product on the Fluid Status and Body Composition--A Randomized Control Trial. PLoS One. 2015 Oct 28;10(10):e0141425. doi: 10.1371/journal.pone.0141425. eCollection 2015. |
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| glucose-based dialysis solution | Other | 2-L exchange; three times a day |
|
|
| 52 weeks |
| peritonitis-free survival, actuarial and technique survival | 52 weeks |
| hospitalization | 52 weeks |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| D002318 | Cardiovascular Diseases |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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