Artero-venous Fistula, Prosthetic Polytetrafluoroethylene Grafts (AVG), Tunneled Cuffed Catheter (TCC): Impact of Vascular Access on HD Inflammation and Monocyte Activation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- serological markers of inflammation (CRP, IL-6, TNF-a)
研究概览
简要总结
The aim of the present study was to investigate patients free of active infection and/or thrombosis to assess if the type of vascular access (AVF, AVG, TCC), could influence:
- the levels of serological markers of inflammation (CRP, IL-6, TNF-a);
- the degree of expression on monocyte surface of inflammation and immune response modulating molecules: CD14, CD32 and CD44.
- the amount of monocytic cells expressing a senescent phenotype (CD14 and CD32).
详细描述
Patients with AVF assumed ticlopidine 250 mg/die, patients with TCC and AVG assumed warfarin to maintain target INR between 1.8 and 2.5.
Six wash out consecutive sessions were carried out before starting the study with Fresenius FX8 Helyxone® , for patients who underwent HD, or with FX 80 Helyxone®, for patients who underwent hemodiafiltration (HDF). After the wash out period, fresh whole blood and serum samples were drawn on starting dialysis, during the midweek HD session for 4 consecutive weeks. For each patient the mean value of the 4 blood samples was considered. All patients continued HD or HDF with FX8 or FX 80 Helyxone® during the whole study period.In order to estimate the normal ranges of the parameters that we evaluated, 60 anonymous healthy volunteers were also submitted to the same assays.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All the patients recruited for the study were infection and thrombosis free from almost 6 months.
- •No patients included had autoimmune disease, hepatic failure, diabetes or malignancy.
- •Patients were not administered ACE inhibitors, angiotensin receptor antagonists, antiinflammatory or immunosuppressive drugs.
- •All the patients had residual GFR < 5 ml/min.
- •The vascular access considered were placed from at least 6 months.
排除标准
- •Patients with recirculating vascular access > 10% were excluded from the study.
- •Patients with acute cardiovascular accident in the last 15 days before starting the study.
结局指标
主要结局
serological markers of inflammation (CRP, IL-6, TNF-a)
时间窗: 6 weeks
monocyte surface of inflammation and immune response modulating molecules: CD14, CD32 and CD44.
时间窗: 6 weeks
monocytic cells expressing a senescent phenotype (CD14 and CD32).
时间窗: 6 weeks
次要结局
未报告次要终点