Insomnia Clinical Trial
Official title:
The Effect and Safety of Combination Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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