Routine and Deferred Dialysis Initiation

Chronic Kidney Disease Clinical Trial

— RADDI  

Official title:

A Randomized, Controlled Trial to Evaluate Routine and Deferred Dialysis Initiation in Chinese Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02423655
• Other study ID #: 201502010
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1049
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (16)

Lead Sponsor

Collaborator

Peking University People's Hospital

Beijing Haidian Hospital/Beijing Haidian Section of Peking University Third Hospital, Beijing Hospital, National Center of Gerontology, Beijing Tongren Hospital, First Affiliated Hospital of Zhejiang University, First Hospital of China Medical University, Hangzhou Hospital of Traditional Chinese Medicine, Peking Union Medical College Hospital, Peking University First Hospital, Ruijin Hospital Affiliated to Shanghai Jiao Tong University, Shaanxi Hospital of Traditional Chinese Medicine, Shengjing Hospital, Sichuan Academy of Medical Sciences, The First Affiliated Hospital of BaoTou Medical College, The First Affiliated Hospital of Zhengzhou University, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (4)

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 — View Citation

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 St — View Citation

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 initiatio — View Citation

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):6 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Nutrition assessment	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   The website of Peking University People's Hospital