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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hemodialysis+hemoperfusion (HA330) | Experimental | Combination of hemodialysis and hemoperfusion (HA330) therapy All subjects in the study phase will receive hemodialysis plus hemoperfusion(HA330) treatment once per week, and regular hemodialysis treatment in the remaining two sessions. |
|
| hemodialysis+hemoperfusion (HA130) | Experimental | Combination of hemodialysis and hemoperfusion (HA130) treatment All subjects in the study phase will receive hemodialysis and hemoperfusion(HA130) treatment once per week, and regular hemodialysis treatment in the remaining two sessions. |
|
| hemodialysis only | Active Comparator | hemodialysis only All subjects in the study phase will receive regular hemodialysis treatment three times per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hemodialysis only | Other | hemodialysis treatment only |
|
| Measure | Description | Time Frame |
|---|---|---|
| the longitudinal changes of itching | every week, up to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| the longitudinal changes of serum middle molecules of β2MG concentrations | The serum concentration of β2MG will be measured using ELISA method | every week,up to 12 weeks. |
| the longitudinal changes of serum middle molecules of iPTH concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xueqing Yu, MD | Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Zhihua Zheng, MD | Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Xunhua Zheng, master | Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1st Affiliated Hospital, Sun Yet-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33283264 | Derived | Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2. |
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| hemodialysis plus hemoperfusion(HA330) | Other | combination of hemodialysis and hemoperfusion (HA330) treatment |
|
| hemodialysis plus hemoperfusion(HA130) | Other | combination of hemodialysis and hemoperfusion (HA130) treatment |
|
The serum concentration of iPTH will be measured using ELISA method
| 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 | 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 | 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 | 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). | every week,up to 12 weeks. |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D011537 | Pruritus |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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