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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Sichuan Academy of Medical Sciences | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
| The First Affiliated Hospital of Zhengzhou University |
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This study evaluates the efficacy and safety of deferred dialysis initiation in Chinese population. 16 tertiary hospitals across China will be randomly assigned into routine and deferred dialysis groups.
The timing for initiating dialysis for progressive chronic kidney disease (CKD) patients is an important issue yet is not well established. There is a strong trend to early dialysis initiation for end stage renal disease (ESRD) patients over the past decades. However, observational data found that early initiation seemed to produce no benefit but additional burden to patients and the health care system. The IDEAL study, the only randomized, controlled trial (RCT) on this issue, found that all-cause mortality, comorbidities and quality of life had no difference between early (glomerular filtration rate, GFR 10-14ml/min/1.73m2) and late (GFR 5-7ml/min/1.73m2) dialysis starters. However there was a big limitation in this study that the difference for average GFR between two groups (12 ml/min/1.73 m2 vs. 9.8 ml/min/1.73m2) was not so separate. Recently, the Canadian Society of Nephrology have released a clinical practice guideline on this issue. The guideline recommends an "intent-to-defer" approach for dialysis initiation and to initiate dialysis in the absence of symptoms in patients with an estimated GFR of 6 ml/min /1.73 m2 or less. In this guideline the specialists also express that the optimal management of patients with an estimated GFR of 6 ml/min per 1.73 m2 or less is based on limited data. There is a gap in knowledge. This research will further evaluate the efficacy and safety of deferred dialysis initiation and fill in this gap. In this study, algorithms will be adopted to determine the timing of dialysis initiation for both routine and deferred dialiysis groups, and the only difference in these two algorithms is the GFR level to initiate dialysis (7 Vs. <5 ml/min per 1.73 m2). The theory that blood access (arteriovenous fistulas) can be timely prepared according to the past GFR decline trajectory will also be tested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deffered Dialysis Initiation | Experimental | Algorithm for deferred dialysis intervention: initiating dialysis in the absence of symptoms in patients with an eGFR of 5 ml/min /1.73 m2 or less |
|
| Routine dialysis Initiation | Active Comparator | Algorithm for routine dialysis intervention: initiating dialysis in the absence of symptoms in patients with an eGFR of 7 ml/min /1.73 m2 (which is the average GFR for patients in Beijing to start dialysis ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Algorithm for deferred dialysis intervention | Other | Use combined indications to guide researchers to defer dialyzing progressive CKD patients. Asymptomatic patient will not start dialysis treatment until his eGFR becomes less than 5 ml/min/1.73m2. Or until 1. Patient's Kraemer index is >6 or with overt fluid overload after trying all conservative means(including appropriate medicines) 2. Patient's Subjective Global Assessment method (SGA) assessment is grade C 3. Patients have indications for emergency dialysis 4. Sever symptoms which cannot be relieved by conservative treatment |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality: Proportion of patients who die from any cause | Proportion of patients who die from any cause during observation period. | From date of enrollment until the end of study, assessed up to 3 years |
| Acute nonfatal cerebro-cardiovascular events before dialysis initiation | Proportion of patients who suffer from acute nonfatal cerebro-cardiovascular events before dialysis initiation. Cerebro-cardiovascular events include acute myocardial infarction,acute coronary ischemia syndrome,acute heart failure, acute exacerbation of chronic heart failure ,severe arrhythmia, stroke, etc. | From date of enrollment until the date of dialysis initiation, or the date of death from any cause,or the end of study, whichever came first, assessed up to 3 year |
| Acute nonfatal cerebro-cardiovascular events after dialysis initiation | Proportion of patients who suffer from acute nonfatal cerebro-cardiovascular events after dialysis initiation. Cerebro-cardiovascular events include acute myocardial infarction,acute coronary ischemia syndrome,acute heart failure, acute exacerbation of chronic heart failure ,severe arrhythmia, stroke, etc. | From date of dialysis initiation until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization: Proportion of patients who are admitted to hospital | Proportion of patients who are admitted to hospital | From date of enrollment until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 year |
| Nutrition assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Zuo | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24066675 | Result | Rosansky SJ, Cancarini G, Clark WF, Eggers P, Germaine M, Glassock R, Goldfarb DS, Harris D, Hwang SJ, Imperial EB, Johansen KL, Kalantar-Zadeh K, Moist LM, Rayner B, Steiner R, Zuo L. Dialysis initiation: what's the rush? Semin Dial. 2013 Nov-Dec;26(6):650-7. doi: 10.1111/sdi.12134. Epub 2013 Sep 19. | |
| 20581422 | Result |
| Label | URL |
|---|---|
| The website of Peking University People's Hospital | View source |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000465 | Algorithms |
| ID | Term |
|---|---|
| D055641 | Mathematical Concepts |
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| OTHER |
| Shaanxi Hospital of Traditional Chinese Medicine | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Shengjing Hospital | OTHER |
| The First Affiliated Hospital of BaoTou Medical College | OTHER |
| Beijing Hospital, National Center of Gerontology | UNKNOWN |
| Beijing Haidian Hospital/Beijing Haidian Section of Peking University Third Hospital | UNKNOWN |
| Beijing Tongren Hospital | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| First Hospital of China Medical University | OTHER |
| Hangzhou Hospital of Traditional Chinese Medicine | OTHER |
| Ruijin Hospital | OTHER |
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|
| Algorithm for routine dialysis intervention | Other | Use combined indications to guide researchers to initiate dialysis in progressive CKD patients routinely. Researchers will start dialysis treatment for a patient when his eGFR reaches 7 ml/min/1.73m2 in asymptomatic patients. Or patients have indications below: 1. Patient's Kraemer index is >6 or with overt fluid overload after trying all conservative means(including appropriate medicines) 2. Patient's SGA assessment is grade C 3. Patients have indications for emergency dialysis 4. Sever symptoms which cannot be relieved by conservative treatment |
|
SGA assessment and serum albumin level are used to assess nutrition status |
| From date of enrollment until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 years, performed every 3 months |
| Patient reported outcome of quality of life | The short form health survey questionnaire 36 will be used. | From date of enrollment until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 years, once every 3 months |
| Complications of dialysis | Proportion of patients who suffer from dialysis complications including blood acess infection, thrombosis, hypotension, etc. | From date of dialysis initiation until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 year |
| Costs | All money patients and insurance agency spend on medical care related with CKD | From date of enrollment until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 years, performed every 3 months |
| Arteriovenous fistulas usage | Proportion of patients using arteriovenous fistulas as their blood access when dialysis initiation. The timing for preparing arteriovenous fistulas depends on the past GFR decline trajectory | From date of enrollment until the date of dialysis initiation, assessed up to 3 years |
| Catheter usage | Proportion of patients using catheter as their blood access when dialysis initiation. | From date of enrollment until the date of dialysis initiation, assessed up to 3 years |
| Cooper BA, Branley P, Bulfone L, Collins JF, Craig JC, Fraenkel MB, Harris A, Johnson DW, Kesselhut J, Li JJ, Luxton G, Pilmore A, Tiller DJ, Harris DC, Pollock CA; IDEAL Study. A randomized, controlled trial of early versus late initiation of dialysis. N Engl J Med. 2010 Aug 12;363(7):609-19. doi: 10.1056/NEJMoa1000552. Epub 2010 Jun 27. |
| 24508475 | Result | Crews DC, Scialla JJ, Boulware LE, Navaneethan SD, Nally JV Jr, Liu X, Arrigain S, Schold JD, Ephraim PL, Jolly SE, Sozio SM, Michels WM, Miskulin DC, Tangri N, Shafi T, Wu AW, Bandeen-Roche K; DEcIDE Network Patient Outcomes in End Stage Renal Disease Study Investigators. Comparative effectiveness of early versus conventional timing of dialysis initiation in advanced CKD. Am J Kidney Dis. 2014 May;63(5):806-15. doi: 10.1053/j.ajkd.2013.12.010. Epub 2014 Feb 6. |
| 24492525 | Result | Nesrallah GE, Mustafa RA, Clark WF, Bass A, Barnieh L, Hemmelgarn BR, Klarenbach S, Quinn RR, Hiremath S, Ravani P, Sood MM, Moist LM; Canadian Society of Nephrology. Canadian Society of Nephrology 2014 clinical practice guideline for timing the initiation of chronic dialysis. CMAJ. 2014 Feb 4;186(2):112-7. doi: 10.1503/cmaj.130363. No abstract available. |
| 31818266 | Derived | Zhao X, Wang P, Wang L, Chen X, Huang W, Mao Y, Hu R, Cheng X, Wang C, Wang L, Zhang P, Li D, Wang Y, Ye W, Chen Y, Jia Q, Yan X, Zuo L. Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population. BMC Nephrol. 2019 Dec 9;20(1):455. doi: 10.1186/s12882-019-1627-0. |
| 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 |