Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Erythropoietin stimulating agents dosage
研究概览
简要总结
Assesment of a predictive model of anemia management: Dosage of erythropoietin (EPO) and Iron adminsitration in hemodialysis patients.
详细描述
Anemia in patients on hemodialysis (HD ) is common and although usually responds well to treatment with Erythropoiesis Stimulating Agents (ESAs ) , this dosage , based on different clinical protocols , often ignores the high variability inter- and intra -individual in patient response . The result leads to swings in the objective by different dosage range that is associated with multiple risks and side effects. There are artificial intelligence-based optimization methods that predict treatment with ESAs in maintaining patient hemoglobin target range . So far the model has been validated for the long half-life of EPO ( darbepoetin ) with promising results.
HYPOTHESIS: Maintaining patients in Hb levels ESAs range using short half-life , avoid the one hand , the need for transfusions and, secondly , the levels exceeding the upper range ( overshooting ), preventing the onset of a increased cardiovascular risk events.
RELEVANCE:The results allow us to validate the model with short half-life ESAs optimizing the management of anemia and improving comorbidity associated with overdosage.
SUMMARY:
Prospective observational study of paired data. Data obtained from the data base Euclid . Data will be collected by clinical teams according to standard clinical practice. Informed at the time of admission to the clinic consent will be obtained . All patient data including to november 15th 2014 and who have completed the study period to 30 april 2015. The results will be compared with those prior to the patient's inclusion in the study were processed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 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
- •> 18 Years
- •> 3 Months on HD / OLHDF
- •Treated with ESAs( epoBeta ) from> 3 Months
排除标准
- •Chronic inflammatory diseases
- •Liver Cirrhosis
- •Active Neoplasms
- •Immunosuppression or other antiinflammatory medication
- •Patients who do not require treatment with ESAs
结局指标
主要结局
Erythropoietin stimulating agents dosage
时间窗: at six months
u/kg/week
Intravenous Iron dosage
时间窗: at six months
mg/mont
次要结局
- anemia parameters(at six months)
- Cardiovascular events(at six months)
研究者
Rosa Ramos
Medical Department Management
NephroCare Spain
