Description of Treatment Patterns and Population Characteristics of Pre-dialysis CKD Patients in the Czech Republic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 5
- 主要终点
- Sociodemographic parameters
研究概览
简要总结
The decision making in the Czech nephrology offices depends on the local common practice which is likely to be heterogenous. In other words, the same patient would be indicated to different therapy and regimen at different sites. To date, the practices and treatment paths have not been described. The aim of the present epidemiological research is to characterize the population of CKD patients at the point of treatment choice and to outline the motivation of nephrologist to initiate particular therapy.
详细描述
This is epidemiological (observational) cross-sectional survey. Data for the research will be obtained from clinical records and patient´s questionnaires and transcribed into electronic case report forms (eCRF) by physician anonymized using subject ID.
This observational research will not impose any additional procedures, assessments, or changes in addition to the routine management of subjects.
The research does not aim to follow treatment with a single medicinal product. The management of patients will be described in general terms. Names of active substances will be collected rather than the names of individual products.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Adult patient of 18 years and older
- •Signed consent with processing of personal data as per the GDPR and the applicable national legal requirements
- •Chronic kidney disease (CKD) category 4 to 5 characterized by GFR < 30 ml/min/1.73m2 for at least 3 months
排除标准
- •Patients on chronic dialysis
- •Patient waiting for kidney transplant
- •Patient requiring indication of dialysis (e.g., life-threatening changes in fluid, electrolyte, and acid-base balance, serositis, pruritus, inability to control blood pressure, lethargy or other changes in mental status, symptoms of uraemia, GFR < 10 ml/min/1.73 m2)
- •Patient with altered mental state unable to fill patient questionnaires
结局指标
主要结局
Sociodemographic parameters
时间窗: through study completion, an average of 3 months
age, gender, ethnicity, health insurance company, education, marital status and cohabitation, employment status/disability, type of employment
次要结局
- Medical history and anthropometry(through study completion, an average of 3 months)
- Functional status/frailty/performance(through study completion, an average of 3 months)
- Decision of future management(through study completion, an average of 3 months)
- Laboratory parameters(through study completion, an average of 3 months)
- Physician attitude to the choice of therapy + reasons(through study completion, an average of 3 months)
- Prognosis(through study completion, an average of 3 months)
- Patient attitude to the choice of therapy + reasons(through study completion, an average of 3 months)
- Nutrition(through study completion, an average of 3 months)