Chronic Kidney Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERAlgorithm for deferred dialysis intervention
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
OTHERAlgorithm for routine dialysis intervention
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
Sponsors
Peking University First Hospital
Sichuan Academy of Medical Sciences
First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Zhengzhou University
Shaanxi Hospital of Traditional Chinese Medicine
Peking Union Medical College Hospital
Shengjing Hospital
The First Affiliated Hospital of BaoTou Medical College
Beijing Hospital, National Center of Gerontology
Beijing Haidian Hospital/Beijing Haidian Section of Peking University Third Hospital
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
First Hospital of China Medical University
Hangzhou Hospital of Traditional Chinese Medicine
Ruijin Hospital
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Nondialysis-dependent stable CKD stage 4-5 patients (eGFR\>7ml/min /1.73 m2) 2. Willing to choose dialysis as his renal replacement therapy method 3. Heart function: grade I or II (NYHA Functional Classification)
Exclusion criteria
1. The life expectancy of patients is estimated to be short (due to causes other than kidney disease); 2. Acute infection occurred in one month; 3. Myocardial infarction, NYHA class IV or stroke events within 3 months; 4. Uncontrolled malignancy; 5. Active viral hepatitis; 6. Active rheumatic disease; 7. Pregnant women, women intending to conceive after enrollment or breastfeeding woman; 8. Planning to take kidney transplantation within the study period; 9. With indices of emergency dialysis; 10. eGFR less than 7 ml/min/1.73m2 in first visit; 11. Under other clinical studies which has an impact on this study; 12. Unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality: Proportion of patients who die from any cause | From date of enrollment until the end of study, assessed up to 3 years | Proportion of patients who die from any cause during observation period. |
| Acute nonfatal cerebro-cardiovascular events before dialysis initiation | 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 | 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. |
| Acute nonfatal cerebro-cardiovascular events after dialysis initiation | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications of dialysis | 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 | Proportion of patients who suffer from dialysis complications including blood acess infection, thrombosis, hypotension, etc. |
| Costs | 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 | All money patients and insurance agency spend on medical care related with CKD |
| Hospitalization: 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 | Proportion of patients who are admitted to hospital |
| Catheter usage | From date of enrollment until the date of dialysis initiation, assessed up to 3 years | Proportion of patients using catheter as their blood access when dialysis initiation. |
| Arteriovenous fistulas usage | From date of enrollment until the date of dialysis initiation, assessed up to 3 years | 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 |
| Nutrition assessment | 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 | SGA assessment and serum albumin level are used to assess nutrition status |
| Patient reported outcome of quality of life | 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 | The short form health survey questionnaire 36 will be used. |
Countries
China
Outcome results
None listed