Hypercytokinemia in maintenance hemodialysis patients
Conditions
Interventions
The use of dialyzer having excellent performance for removal of cytokines.
The use of conventional dialyzers.
Sponsors
Tokai Cytokine Removal Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Stable hemodialysis patients who are receiving hemodialysis more than 7 years. 2) Patients who are using polysulfone dialyzers (PS, PES, PEPA) other than NV series.
Exclusion criteria
Exclusion criteria: 1) Patients who are receiving renal replacement therapies other than hemodialysis, continuous ambulatory peritoneal dialysis and hemodiafiltration, excluding hemodialysis. 2) Patients who are enrolled to other clinical study. 3) Cancer bearing patients or a patient who received radical surgery for cancer in less than 3 years. 4) Patients who have a history of cardiovascular diseases (myocardial infarction, stroke) in less than 6 months. 5) Patients who have peripheral arterial disease classified in more than Fontaine classification class II. 6) Patients who have uncontrolled diabetes despite standard treatments. 7) Patients who are considered to have acute inflammation with CRP of higher than 2 mg/dL. 8) Patients with uncontrolled anemia (Hb <8.5 g/dL) despite ESA treatment. 9) Patients who are pregnant or intends to become pregnant within one year. 10) Patients who are judged as the inadequate subject of this study by the doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Removal performance of pro-inflammatory cytokine (IL-6). (Clearance is measured at 1 and 4 hr after the beginning of session. Removal rate is measured at 4 hr after the beginning of session.) 2) Blood concentration of inflammatory cytokine (IL-6) is measured every four months for one year. Sample is collected before each session. 3) Clinical observation (MIS evaluation) are recorded every four months for one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Dialysis dose: BUN(KT/V), B2-MG 2) Physique, electrolyte: BMI, Na, K, Cl, chest x-ray (CTR) 3) Mineral metabolism: P, Ca, int-PTH 4) Anemia: Hb, ESA dose, serum TIBC 5) Nutritional status: Alb 6) Inflammatory status: high sensitive CRP 7) Hemodynamics: blood pressure at 0, 30, 60, 120, 180, and 240 minutes after the beginning of session. 8) Clinical observation: Clinical observations are described in the following 3 items. (1) Atherosclerosis (cold feeling in lower leg, paralysis). (2) Eating disorder and nutritional status. (3) Inflammatory status. | — |
Countries
Japan
Contacts
Public ContactTakatoshi Kakuta
Tokai University School of Medicine Division of Nephrology, Endocrinology and Metabolism
Outcome results
None listed