Effect of the use of dialyzer having excellent performance for removal of cytokines on clinical observation in maintenance HD patients
- Conditions
- Hypercytokinemia in maintenance hemodialysis patients
- Registration Number
- JPRN-UMIN000010357
- Lead Sponsor
- Tokai Cytokine Removal Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.