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Patient recruitment difficulties
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| Name | Class |
|---|---|
| First Hospital of China Medical University | OTHER |
| Beijing Anzhen Hospital | OTHER |
| The Luhe Teaching Hospital of the Capital Medical University | OTHER |
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This is a multi-center, controlled clinical trial study. The purpose of this study is to examine the efficacy and safety of automated peritoneal dialysis as compared with intermittent haemodialysis for ESRD patients with indications for urgent start dialysis.
Hemodialysis(HD) and peritoneal dialysis (PD) are both the main methods to treat with end-stage renal disease (ESRD) uremia patients. The first 3-month mortality and hospitalization rate of new dialysis patient is much higher than that of regular dialysis's. So it is very important to set up dialysis pathway and from inducing dialysis into regular dialysis smoothly. But in the global 50-70%, more than 70% of the patients in China can not establish the dialysis pathway in advance according to the plan. With the common, a temporary deep venous catheter would be used first, then the fistula established later, as the final transition for hemodialysis. Urgent peritoneal dialysis can be established 24 hours after the establishment of permanent access dialysis, simply and easily, it can protect the residual kidney function; reduce treatment costs, hemodynamic stability, no anticoagulant is its unique advantages, At the same time, also avoid the temporary deep venous pathway prone to local bleeding, infection, venous thrombosis, central venous stenosis, direct impact on the future of the mature of fistula , or transplanted kidney vascular conditions. Automatic peritoneal dialysis (APD) in the treatment of urgent dialysis patients can save more manpower and resources, and improve the efficiency of peritoneal dialysis. The study on the efficacy and safety of urgent dialysis lacks the precisely designed multi-center, prospective and controlled clinical trial, and APD only induces 3 days, it is difficult to really reflect the safety and effectiveness of APD. Therefore, it is of great practical significance to study the difference of safety, efficacy and cost-effectiveness between urgent PD and HD in a prospective, control and multicenter clinical trial. 206 ESRD uremia patients will involve in this multi-center, prospective and controlled clinical trial, the mode of urgent dialysis will choose by patient guided by nephrologist, the HD group will receive the standard traditional treatment: from induction HD to regular HD. The PD group will receive the APD daily. All patient will be monitor the physiological and biochemical marker for 14 day, and all adverse events and dead within 90days will collected to evaluated the safety, efficacy of the two urgent dialysis modes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APD group | Experimental | Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment |
|
| IHD group | Active Comparator | Subjects will receive un-tunneled hemodialysis catheter placement and subsequent hemodialysis treatment 3-4 times per week,2-4 hours each time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| automated peritoneal dialysis | Procedure | peritoneal dialysis administered by a cycler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| infective morbidity | peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD) | At 14 days after the initiation of dialysis |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical complications morbidity | catheter leakage and migration (APD), catheter obstruction (IHD), Exit site bleeding, pneumothorax, hernia | At 14 and 90 days after the initiation of dialysis |
| dialysis related mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Limeng Chen, MD | Division of Nephrology, Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing Municipality | 100029 | China | ||
| Peking Union Medical College Hospital |
To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted
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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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| Ningbo No.2 Hospital |
| OTHER |
the mode of urgent dialysis will choose by patient guided by nephrologist, the HD group will receive the standard traditional treatment: from induction HD to regular HD. The PD group will receive the APD daily.
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| IHD |
| Procedure |
HD 4hour 2-3times per week |
|
catheter-related:Sepsis, severe thromboembolic events (massive cerebral infarction, pulmonary embolism), arrhythmia (ventricular tachycardia, ventricular fibrillation),bleeding, Congestive heart failure and ischemic heart disease
| At 14 and 90 days after the initiation of dialysis |
| infective morbidity | peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD) | At 90 days after the initiation of dialysis |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Beijing Luhe Hospital Affiliated to Capital Medical University | Beijing | Beijing Municipality | 101149 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Ningbo No.2 Hospital | Ningbo | Zhejiang | 315000 | China |
| 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 |