Routine and Deferred Dialysis Initiation

Not Applicable

• Conditions: Chronic Kidney Disease
• Interventions: Other: Algorithm for deferred dialysis intervention; Other: Algorithm for routine dialysis intervention

• Registration Number: NCT02423655
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Study Start: 2015-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-16
• Primary Completion: 2020-08
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1049

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deffered Dialysis Initiation	Algorithm for deferred dialysis intervention	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	Algorithm for routine dialysis intervention	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 )

Primary Outcome Measures

Name	Time	Method
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 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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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
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
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
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.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China