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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.
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.
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with severely decreased renal function or with renal failure (CKD category 4 to 5 as per KDIGO 2012 (2), i.e., GFR < 30 ml/min/1.73 m2 for at least 3 months) naïve to dialysis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Tužil, Mgr. | Contact | 727824059 | +420 | jan.tuzil@valueoutcomes.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FMC Sokolov | Recruiting | Sokolov | Carlsbad Region | 35601 | Czechia |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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 |
| FMC Nemocnice Mělník | Recruiting | Mělník | Central Bohemia | 27601 | Czechia |
|
| Thetis Seirenia Brno | Recruiting | Brno | South Moravian | 63900 | Czechia |
|
| Nemocnice Havlíčkův Brod | Recruiting | Havlíčkův Brod | Vysocina | 58022 | Czechia |
|
| Nemocnice Jihlava | Recruiting | Jihlava | Vysocina | 58601 | Czechia |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |