The incidence and prevalence of chronic kidney disease are increasing worldwide, as is the number of patients progressing to End-Stage Renal Disease (ESRD). China has experienced an increased accessibility and affordability of dialysis treatment, which in turn has brought about an increase in the number of patients receiving Renal Replacement Therapy (RRT).Without RRT, either in the form of maintenance dialysis or transplantation, ESRD is fatal. The scope of the trial is to observe the performance of Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line versus AK 200 Ultra S, extracorporeal circulation conduct of blood purification apparatus and Ultra Steriset as the comparator devices in treatment of patients using hemodialysis (HD) or hemodiafiltration (HDF) for ESRD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
The HDF session will be performed in post-dilution volume-controlled mode, with a minimum target total convective volume (VCtot) of 16 L and blood flow rate (QB) set at 200-300 mL/min.
The HDF session will be performed in post-dilution volume-controlled mode, with a minimum target total convective volume (VCtot) of 16 L and blood flow rate (QB) set at 200-300 mL/min.
Investigational Site
Beijing, Beijing Municipality, China
Investigational Site
Foshan, Guangdong, China
Investigational Site
Wuhan, Hubei, China
Investigational Site
Nanjing, Jiangsu, China
Investigational Site
Shenyang, Liaoning, China
Investigational Site
Hangzhou, Zhejiang, China
Investigational Site
Wenzhou, Zhejiang, China
Number of participants successfully completing HDF without interruption of therapy during Dialysis
Defined as participants not having an interruption in therapy for greater than 15 continuous minutes due to a technical reason of all the enrolled patients in the same group. If there is more than one interruption due to technical reasons, the criteria for failure should be the sum of all interruptions being greater than 15 minutes.
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Number of Participants by Level of Effectiveness of Disposable Tubing during and after Dialysis
Participant recorded as "yes" or "no" by categories of (1) blood flow in the tubing is smooth without obstruction, blood flow rate meets requirement of the patient's hemodialysis prescription and finish the dialysis procedure, the (2) connections are free from blood and air leakage and detachment, (3) there is no folding, cracking or rupture in tubing during dialysis procedure.
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Reduction ratio of β2-Microglobulin during and after Dialysis
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Single-pool Kt/V urea during and after Dialysis
Computing formula: spKt/V = -ln (R - 0.008t) + (4 - 3.5R) x (ΔBW/BW). Where R is the blood urea after hemodialysis/ blood urea before hemodialysis; t is time in hours; ΔBW is the weight change values after hemodialysis, namely ultrafiltration volume in liters; BW is weight in kilograms.
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Urea Reduction Ratio (URR) during and after Dialysis
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Number of Participants by Level of Appearance of Disposable Tubing during and after Dialysis
Participants with tubing as flexible, transparent, and smooth (it is easy to observe the presence of bubbles) recorded categorically as "yes" or "no."
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Number of Participants by Level of Elasticity of Pump Lines during and after Dialysis
Participants with the blood and fluid lines showing good elasticity and good resilience after being rolled without obvious deformity after dialysis recorded categorically as "yes" or "no."
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
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