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临床试验/NCT02337335
NCT02337335Unknown不适用

Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients

NephroCare Spain1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2014年11月最近更新:
适应症

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

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

发起方
NephroCare Spain
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Rosa Ramos

Medical Department Management

NephroCare Spain

研究点 (1)

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