Routine and Deferred Dialysis Initiation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1049 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Deffered Dialysis Initiation

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

Group Type EXPERIMENTAL

Algorithm for deferred dialysis intervention

Intervention Type 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

Routine dialysis Initiation

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 )

Group Type ACTIVE_COMPARATOR

Algorithm for routine dialysis intervention

Intervention Type 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

Interventions

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Algorithm 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

Intervention Type OTHER

Algorithm 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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No