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| ID | Type | Description | Link |
|---|---|---|---|
| VGHUST97-P1-01 | Other Grant/Funding Number | Taipei Veterans General Hospital, Taiwan |
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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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Hemodialysis (HD) may lead to increase inflammatory response through a number of mechanisms. HD-related inflammation is mainly due to underlying kidney disease, coexisting comorbidities, uremia per se, dialyzer membrane biocompatibility and contaminated dialysis fluid. Accordingly, HD patients are chronically exposed to microinflammation as a result of blood-membrane interaction and dialysis fluid contamination. Among these factors, biofilm formation and contaminated dialysis fluid are closely related to enhanced immune activation in HD patients. Furthermore, only dialysis fluid quality is controllable and preventable. Therefore, to reduce the cardiovascular (CV) events and improve the outcome, it prompts us to conduct a prospective randomized controlled study to explore whether heat disinfection link in HD water treatment system can effectively prevent biofilm formation, to ensure the dialysis fluid purity, and subsequently to improve the patient outcome, in terms of CV events and mortality.
Inflammation is common in individuals with both chronic kidney disease (CKD) and hemodialysis (HD). HD may lead to increased inflammatory response through a number of mechanisms; some of these factors also result in pro-inflammatory cytokine release and consequently cause the overlap between anemia, accelerated atherosclerosis and inflammation. HD-related inflammation is mainly due to underlying kidney disease, coexisting comorbidities, uremia per se, dialyzer membrane biocompatibility and contaminated dialysis fluid. Accordingly, HD patients are chronically exposed to microinflammation as a result of blood-membrane interaction and dialysis fluid contamination. Among these factors, biofilm formation and contaminated dialysis fluid are closely related to enhanced immune activation in HD patients. Furthermore, only dialysis fluid quality is controllable and preventable. Therefore, to correct rHuEPO poor response and reduce the cardiovascular (CV) events, it prompts us to conduct a prospective randomized controlled study to explore as to whether heat disinfection link in HD water treatment system can effectively prevent biofilm formation, to ensure the dialysis fluid purity, and subsequently to improve the patient outcome, in terms of CV events and mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heat disinfection | Experimental | Experimental arm: Heat disinfection link to RO water treatment system and piping system to dialysis machine |
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| Conventional RO water treatment | No Intervention | Placebo arm: conventional chemical disinfection link to RO water treatment system. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CWP 103H (Gambro, Sweden): a heat disinfection device | Device | Heat disinfection can increase temperature to 95c in the RO water treatment system and then in the piping system link to dialysis machines in each hemodialysis center per night |
| Measure | Description | Time Frame |
|---|---|---|
| CV events, CV | 5 years | |
| all-cause mortality | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| biofilm formation | 5 years | |
| endotoxin level of dialysis water | 5 years | |
| pro-inflammatory cytokine levels in serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Der-Cherng Tarng, MD, PhD | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
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| ID | Term |
|---|---|
| D007688 | Kidneys, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| 5 years |