NCT02423655

Routine and Deferred Dialysis Initiation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,049 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2015-07-01
• Primary completion: 2020-08-01
• Completion: 2020-12-01
• First posted: 2015-04-22
• Last updated: 2019-04-16

Locations

1 site across 1 country: China