NCT01723111已完成不适用
A Prospective, Multicenter, Observational Study to Evaluate the Impact of Peritoneal Dialysis Compared With Hemodialysis on Iron Metabolism and Hepcidin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- ESA (Erythrocyte stimulating agents) dose
研究概览
简要总结
- Dialysis modality may influence the oxidative stress and proinflammatory cytokines in ESRD patients.
- Dialysis modality may affect hepcidin
- Dialysis modality may influence iron and ESA requirements.
详细描述
It has been considered that PD patients tended to be less anemic and require lower ESA dose than HD patients. In addition, it was also known that the level of oxidative stress and inflammatory cytokines tended to be lower in PD patients than HD patients. And hepcidin synthesis is markedly increased during inflammation. Altogether, Lower ESA requirement in PD patients may be associated with lower hepcidin level due to lower inflammatory state compared with HD patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age 18 years or older
- •Dialysis treatment was expected over 3 months
- •In HD patients, regular hemodialysis 4 h a session more than two times a week
- •In PD patients, over 2 exchange with more than 1.5 L solution
排除标准
- •Poorly controlled hypertension, i.e. sitting blood pressure exceeding 180/110 despite medication requiring hospitalization or interruption of ESA treatment
- •Significant acute or chronic bleeding such as overt gastrointestinal bleeding within the previous 3 months
- •Active malignant disease (except non-melanoma skin cancer and patients with malignant disease who have been disease-free for at least the 5 previous years are eligible)
- •Acute infection
- •Hemolysis
- •Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
- •Megaloblastic anemia
- •Platelet count >500 x 109/L or <100 x 109/L
- •Pure red call aplasia
- •Epileptic seizure during previous 3 months
- •Women of childbearing potential without effective contraception
- •Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol
- •Planned elective surgery during the study period except for cataract surgery or laser photocoagulation
- •Life expectancy less than 12 month
结局指标
主要结局
ESA (Erythrocyte stimulating agents) dose
时间窗: six months
We will compare ESA dose between PD patients and HD patients
次要结局
- Hepcidin level(six months)
- hs-CRP(six months)
- IL-6(six months)
- Total antioxidant capacity(six months)
- IV iron treatment (% of patients)(six months)
- Transfusion rate(six months)
- Myeloperoxidase(six months)
- TNF-a(six months)
研究者
Yong-Lim Kim
MD, PhD
Kyungpook National University Hospital
研究点 (4)
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