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

NCT05380843 | Unknown

• 1 other identifier: NephroSCREEN
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (32)

• Medical history and anthropometry

  through study completion, an average of 3 months

• Medical history and anthropometry

  through study completion, an average of 3 months

• Medical history and anthropometry

  through study completion, an average of 3 months

• Medical history and anthropometry

  through study completion, an average of 3 months

• Medical history and anthropometry

  through study completion, an average of 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Value Outcomes Ltd.: lead

Study Sites (5)

FMC Nemocnice Mělník

Mělník, Central Bohemia, 27601, Czechia

RECRUITING

FMC Sokolov

Sokolov, Karlovarský kraj, 35601, Czechia

RECRUITING

Nemocnice Havlíčkův Brod

Havlíčkův Brod, Kraj Vysočina, 58022, Czechia

RECRUITING

Nemocnice Jihlava

Jihlava, Kraj Vysočina, 58601, Czechia

RECRUITING

Thetis Seirenia Brno

Brno, South Moravian, 63900, Czechia

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jan Tužil, Mgr.

CONTACT

727824059; jan.tuzil@valueoutcomes.cz

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 19, 2022
• Study Start: May 16, 2022
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (5)