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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR-TRC-13003001 | Registry Identifier | Chinese Clinial Trial Registry |
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This study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients.
This study is a prospective, randomized, parallel, controlled, multi-center clinical study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate.It aims to investigate the proper dialysis dose for Chinese CAPD patients.At the same time,it can evaluate the effectiveness and safety of Chinese product Huaren Peritoneal Dialysate and peritoneal dialysis product Baxter Peritoneal Dialysate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Huaren peritoneal dialysate | Experimental | Huaren Peritoneal dialysate CAPD 3-5 times/d |
|
| Baxter Peritoneal Dialysate | Active Comparator | Baxter Peritoneal dialysate CAPD 3-5 times/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huaren Peritoneal Dialysate | Drug | Huaren Peritoneal dialysate CAPD 3-5 times/d |
|
| Measure | Description | Time Frame |
|---|---|---|
| survival rate | 1,2,3,4,5 years |
| Measure | Description | Time Frame |
|---|---|---|
| PD technique survival rate | 1,2,3,4,5 years | |
| estimated glomerular filtration rate decline | 1,2,3,4,5 years | |
| nutritional status |
| Measure | Description | Time Frame |
|---|---|---|
| AE, vital signs, laboratory tests | 1,2,3,4,5 years | |
| peritonitis | 1,2,3,4,5 years | |
| quality of products |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CHEN Xiangmei, yes | Chinese PLA General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26715594 | Derived | Zhou J, Cao X, Lin H, Ni Z, He Y, Chen M, Zheng H, Chen X. Safety and effectiveness evaluation of a domestic peritoneal dialysis fluid packed in non-PVC bags: study protocol for a randomized controlled trial. Trials. 2015 Dec 29;16:592. doi: 10.1186/s13063-015-1131-1. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Baxter Peritoneal Dialysate | Drug | Baxter Peritoneal dialysate CAPD 3-5 times/d |
|
| 1,2,3,4,5 years |
| quality of life(SF-36) | 1,2,3,4,5 years |
| cardiovascular events | 1,2,3,4,5 years |
| increments of dialysis dose | 1,2,3,4,5 years |
| medical costs | 1,2,3,4,5 years |
| dropout rate | 1,2,3,4,5 years |
| 1,2,3,4,5 years |
| allergy to PD fluids, bags and tubes | 1,2,3,4,5 years |
| 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 |