A prospective, randomized, controlled open clinic trial to evaluate the effect and safety of combination of conventional hemodialysis(HD) and hemoperfusion(HP) on middle molecules removal and complications improvement in long-term maintenance hemodialysis (MHD) patients. There are two phases of study for each subject. Phase 1 (screening phase). During this phase, each potential subject will be evaluated to determine if he/she is eligible for the study. Phase 2 (intervention phase). Each subject will be randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3 months.
All patients recruited from these centers who met the inclusion criteria were randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3 months. Hemoperfusion is performed by HA130 or HA330 resin adsorbents. Blood flow is 200ml/min，dialysate flow is 500ml/min， hemodialysis and hemoperfusion last for 2.5h，continue HD after removing the adsorbent to complete 4 hours'treatment.Heparin for anticoagulation ：first pulse 0.5-1mg/kg ，appending 8-10mg/h. Primary endpoint is the improvement of the clinic symptoms, meanwhile secondary endpoint is serum β2MG、iPTH、CRP、ADMA、BMP2 decrease compared with the baseline, life quality, nutrition condition, and cardiovascular (CVD) incidence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
hemodialysis treatment only
combination of hemodialysis and hemoperfusion (HA330) treatment
combination of hemodialysis and hemoperfusion (HA130) treatment
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, China
the longitudinal changes of itching
Time frame: every week, up to 12 weeks.
the longitudinal changes of serum middle molecules of β2MG concentrations
The serum concentration of β2MG will be measured using ELISA method
Time frame: every week,up to 12 weeks.
the longitudinal changes of serum middle molecules of iPTH concentrations
The serum concentration of iPTH will be measured using ELISA method
Time frame: every week,up to 12 weeks.
the longitudinal changes of serum middle molecules of CRP concentrations
The serum concentration of CRP will be measured using ELISA method
Time frame: every week,up to 12 weeks.
the longitudinal changes of serum middle molecules of ADMA concentrations
The serum concentration of ADMA will be measured using ELISA method
Time frame: every week,up to 12 weeks.
the longitudinal changes of serum middle molecules of BMP2concentrations
The serum concentration of BMP2 will be measured using ELISA method
Time frame: every week,up to 12 weeks.
the longitudinal changes of the nutritional status
The nutritional status was evaluated using the serum level of albumin, the subjective global assessment score and BMI. The serum level of albumin will measured using the blood analysis biochemical analyzer, the subjective global assessment score will measured using the SGA scale and the BMI will measured through the physical examination and calculated by weight (kg)/height2 (m2).
Time frame: every week,up to 12 weeks.
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