Clinical trial NCT05380843: Description of Treatment Patterns and Population Characteristics of Pre-dialysis CKD Patients in the Czech Republic
Official title: Description of Treatment Patterns and Population Characteristics of Pre-dialysis CKD Patients in the Czech Republic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Diseases
Keywords: epidemiological survey
renal failure
decreased renal function
dialysis
low protein diet
treatment alternatives
Clinical Frailty Scale
Mini Nutritional Assessment (MNA)
Bansal Score
Lead sponsor: Value Outcomes Ltd.
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sociodemographic parameters
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Medical history and anthropometry
timeFrame: through study completion, an average of 3 months
measure: Medical history and anthropometry
timeFrame: through study completion, an average of 3 months
measure: Medical history and anthropometry
timeFrame: through study completion, an average of 3 months
measure: Medical history and anthropometry
timeFrame: through study completion, an average of 3 months
measure: Medical history and anthropometry
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Laboratory parameters
timeFrame: through study completion, an average of 3 months
measure: Prognosis
timeFrame: through study completion, an average of 3 months
measure: Functional status/frailty/performance
timeFrame: through study completion, an average of 3 months
measure: Nutrition
timeFrame: through study completion, an average of 3 months
measure: Decision of future management
timeFrame: through study completion, an average of 3 months
measure: Physician attitude to the choice of therapy + reasons
timeFrame: through study completion, an average of 3 months
measure: Patient attitude to the choice of therapy + reasons
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Thetis Seirenia Brno
state: Jihomoravský Kraj
city: Sokolov
country: Czechia
facility: FMC Sokolov
state: Karlovarský Kraj
city: Havlíčkův Brod
country: Czechia
facility: Nemocnice Havlíčkův Brod
state: Kraj Vysočina
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava
state: Kraj Vysočina
city: Mělník
country: Czechia
facility: FMC Nemocnice Mělník
state: Středočeský Kraj
Study officials:
References: