Description of Treatment Patterns and Population Characteristics of Pre-dialysis CKD Patients in the Czech Republic

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Description of Treatment Patterns and Population Characteristics of Pre-dialysis CKD Patients in the Czech Republic

Conditions
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Chronic Kidney Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic parameters | age, gender, ethnicity, health insurance company, education, marital status and cohabitation, employment status/disability, type of employment | through study completion, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical history and anthropometry | BMI (in kg/m^2) | through study completion, an average of 3 months | 
| Medical history and anthropometry | blood pressure (systolic/diastolic, in mmHg) | through study completion, an average of 3 months | 
| Medical history and anthropometry | time since CKD diagnosis (in years), time since stage 4 CKD (in years), previous referral to nephrology (in years) | through study completion, an average of 3 months | 
| Medical history and anthropometry | smoking, abusus | through study completion, an average of 3 months | 
| Medical history and anthropometry | aetiology of CKD, comorbidities, current pharmacotherapy | through study completion, an average of 3 months | 
| Laboratory parameters | albumin (in g/l) | through study completion, an average of 3 months | 
| Laboratory parameters | glycaemia (in mmol/l) | through study completion, an average of 3 months | 
| Laboratory parameters | CRP (in mg/l) | through study completion, an average of 3 months | 
| Laboratory parameters | serum creatinine (in μmol/l) | through study completion, an average of 3 months | 
| Laboratory parameters | serum calcium (in mmol/l) | through study completion, an average of 3 months | 
| Laboratory parameters | LDL and HDL cholesterol (in mmol/l) | through study completion, an average of 3 months | 
| Laboratory parameters | serum urea (in mmol/l) | through study completion, an average of 3 months | 
| Laboratory parameters | plasma potassium (in mmol/l) | through study completion, an average of 3 months | 
| Laboratory parameters | serum PTH (pmol/l) | through study completion, an average of 3 months | 
| Laboratory parameters | albuminuria (in mg/l) | through study completion, an average of 3 months | 
| Laboratory parameters | serum phosphorus (mmol/l) | through study completion, an average of 3 months | 
| Laboratory parameters | haematuria (erythrocytes/μl) | through study completion, an average of 3 months | 
| Laboratory parameters | urine creatinine (mmol/l) | through study completion, an average of 3 months | 
| Laboratory parameters | blood count - WBC (10^9/l) | through study completion, an average of 3 months | 
| Laboratory parameters | blood count - RBC (10^12/l) | through study completion, an average of 3 months | 
| Laboratory parameters | blood count - MCV (fl) | through study completion, an average of 3 months | 
| Laboratory parameters | blood count - MCHC (g/l) | through study completion, an average of 3 months | 
| Laboratory parameters | blood count - HCT | through study completion, an average of 3 months | 
| Laboratory parameters | blood count - HGB (g/l) | through study completion, an average of 3 months | 
| Laboratory parameters | blood count - PLT (10^9/l) | through study completion, an average of 3 months | 
| Laboratory parameters | blood count - RDW (%) | through study completion, an average of 3 months | 
| Prognosis | Bansal score (min. 0, max. 17, higher score means the worse prognosis) | through study completion, an average of 3 months | 
| Functional status/frailty/performance | Clinical frailty scale (min. 1, max. 9, higher score means higher frailty) | through study completion, an average of 3 months | 
| Nutrition | nutritional status (Full MNA assessment), ketoanalogues, salt intake, protein intake, nutritional education (flyers, consultations etc.), attitude/future adherence to prescribed dietary restrictions | through study completion, an average of 3 months | 
| Decision of future management | Choice of future management (conservative management, conservative management with ketoanalogues, dialysis) | through study completion, an average of 3 months | 
| Physician attitude to the choice of therapy + reasons | Physician motivation/reasons for treatment choices | through study completion, an average of 3 months | 
| Patient attitude to the choice of therapy + reasons | Patient motivation/reasons for treatment choices | through study completion, an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bansal Score, epidemiological survey, renal failure, decreased renal function, dialysis, low protein diet, treatment alternatives, Clinical Frailty Scale, Mini Nutritional Assessment (MNA)