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Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients.
Design: prospective,randomized,controlled,single center study
Study hypothesis: Patients on peritoneal dialysis are frequently hypervolemic, which is associated with increasing hazard of death and cardiovascular events. Bioimpedance analysis is a safe, and easy way, which appears to be more useful and sensitive than other techniques for assessing volume status in dialysis patients. Therefore we hypothesize that more concise and strict fluid management guided by BIA may help to improve patients' survival, decrease cardiovascular events and hospitalization rate.
Objects: incident and prevalent patients with overhydration status.
Primary Outcome: all cause mortality. Secondary Outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bioimpedance monitoring group | Experimental | patients whose fluid status will be monitored and guided by bioimpedance analysis |
|
| clinical monitoring group | Other | patients whose fluid status will be monitored and guided by clinical experience |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bioimpedance monitoring | Device | To assess the body composition using Multi-frequency bioelectrical impedance analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| death | all cause mortality;cardiovascular related mortality | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| technique failure | permanent hemodialysis transfer | 12 months |
| cardiovascular events | heart failure, myocardial infarction,angina, Percutaneous coronary stenting, coronary artery bypass grafting, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xuqing Yu, MD,PHD | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D004487 | Edema |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D026661 | Clinical Trials Data Monitoring Committees |
| ID | Term |
|---|---|
| D011367 | Professional Staff Committees |
| D011785 | Quality Assurance, Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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| clinical monitoring | Other | clinical symptom and examination,such as edema, body weight, blood pressure, cardial function |
|
|
| 12 months |
| clinical adverse events | hospitalization events due to overload; Non-PD related infection; PD related peritonitis; peripheral angiopathy | 12 months |
| residual renal function | change of baseline residual renal function, measured as residual glomerular filtration rate(rGFR) and urine volume | 12 months |
| 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 |
| D012816 | Signs and Symptoms |