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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.
Full description
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.
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20 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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