The Use of Sorption Technologies in Patients Receiving Program Hemodialysis With Inflammatory Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in serum IL-6, pg/ml
研究概览
简要总结
Use of sorption technologies in patients undergoing maintenance hemodialysis with inflammatory syndrome and clinical manifestations of uremia
详细描述
This study will involve 30 hemodialysis patients selected based on examination results showing elevated C-reactive protein (CRP) and/or interleukin-6 (IL-6) levels. Participants will undergo hemoadsorption with the Jafron HA130 cartridge performed concurrently with hemodialysis: three times per week during the first month, twice per week during the second month, and once per week during the third month.
The following parameters will be assessed: inflammatory markers (CRP, IL-1, IL-6, IL-8, β2-microglobulin, free light chains of immunoglobulins), parathyroid hormone (PTH), standard biochemical blood tests (creatinine, urea, calcium, phosphorus, albumin, iron metabolism), and complete blood count. Analyses will be performed at baseline (before inclusion) and monthly thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adequate dialysis defined by a KT/V index ≥ 1.4
- •No active inflammatory process or infection
- •Age ≥ 18 years
- •Receiving standard hemodialysis regimen three times weekly, at least 4 hours per session
- •Participants with elevated interleukin-6 (IL-6) and/or C-reactive protein (CRP) levels exceeding local laboratory reference values
排除标准
- •Current use of steroids or immunosuppressive therapy
- •History of kidney transplantation
- •Diagnosis of cancer
结局指标
主要结局
Change from baseline in serum IL-6, pg/ml
时间窗: By the third month
次要结局
- Change frome baseline in serum IL-1, pg/ml(Monthly for 3 months)
- Change from baseline in ferritin, mcg/L(Monthly for 3 months)
- Change from baseline in serum IL-8, pg/ml(Monthly for 3 months)
- Change from baseline in serum IL-10, pg/ml(Monthly for 3 months)
- Change from baseline in CRP, mg/L(Monthly for 3 months)
- Change from baseline in free light chains, mcg/ml(Monthly for 3 months)
- Change from baseline in PTH, pg/ml(Monthly for 3 months)
- Change from baseline in saturated transferrin, TS%(Monthly for 3 months)
- Change from baseline in blood urea nitrogen (BUN), mmol/L(Monthly for 3 months)
- Change from baseline in creatinine, mg/dL(Monthly for 3 months)
- Change from baseline in pruritus (Visual Analogue Scale)(Monthly for 3 months)
- Change from baseline in calcium, mmol/L(Monthly for 3 months)
- Change from baseline in β2-microglobulin, mg/L(Monthly for 3 months)
- Change from baseline in serum iron, mcg/dL(Monthly for 3 months)
- Change from baseline in albumin, g/L(Monthly for 3 months)
- Change from baseline in phosphorus, mmol/L(Monthly for 3 months)
- Change from baseline in hemoglobin (Hb), g/L(Monthly for 3 months)
- Change from baseline in Hospital Anxiety and Depression Scale Score(Monthly for 3 months)
研究者
Evgeny Shutov
Head of the Nephrology Center, Botkin Hospital
Botkin Hospital