N18.9
Conditions
Interventions
Group 1: Single-arm observational study with two study visits (baseline and 12-month follow-up). This arm includes all participants of the study niere.schützen 2.0.
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: - men and women of all ethnical groups aged between 40 and 65 years - treated by a general practitioner with a § 2 health insurance contract - written consent to participate in the study Presence of at least one of the following risk factors: - arterial hypertension (documented diagnosis of hypertension for at least 3 months, defined as systolic blood pressure >140 and diastolic blood pressure >90 mmHg) - diabetes mellitus (defined as Typ 1 and Typ 2) - adipositas (defined as body mass index > 30 -g/m2) - end stage renal disease in the familiy (family is defined as children, parents and siblings) - history of cardiovascular diseases (stroke, transient ischemic attack (TIA), coronary heart disease, peripheral arterial disease)
Exclusion criteria
Exclusion criteria: - prior recorded diagnosis of CKD (defined as a documentation of chronic kidney disease) - prior participation in “kidney.care” (recorded eGFR/ACR diagnosis according to “kidney.care” in the outpatient setting) - kidney transplant recipients - dialysis patients - participants with an eGFR < 15 ml/min/1.73 m2 - participants with acute serious illness - carcinoma patients - NYHA III and IV - expected life expectancy < 6 months - Unable or unwilling to give informed consent (If a person cannot communicate with staff, s/he is unable to provide informed consent.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To answer the primary question of how many patients in the risk population have CKD, the prevalence will be calculated. As patients are recruited in different practices, the accuracy of the prevalence estimate is influenced by the design effect DE, which is taken into account in the calculation of the 95% confidence intervals. Cases of CKD are defined as eGFRcreat-cys <60 ml/min per 17.3 m2 or ACR = 30 mg/g/g (=G3 and/or =A2). The source data will be evaluated at the baseline visit and at the 12-month follow-up visit and will include the paper worksheets, control scheme results and laboratory results. | — |
Secondary
| Measure | Time frame |
|---|---|
| All participant’s baseline and 12-month follow-up data will be analysed descriptively. Therefore, the following data will be analysed: - age and sex - weight - height - arterial hypertension (documented diagnosis of hypertension for at least 3 months, defined as systolic blood pressure >140 and diastolic blood pressure >90 mmHg) - diabetes mellitus (defined as Typ 1 and Typ 2) - adipositas (Adipositas will be defined as body mass index > 30) - end stage renal disease in the familiy (family is defined as children, parents, and siblings) - history of cardiovascular diseases (stroke, TIA, coronary heart disease, peripheral arterial disease) - concominant medication (use of antihypertensive, statine, NSAR, antidiabetic medication including SGLT2-inhibitors), including changes of medication - laboratory results (eGFR, ACR) - fast and slow progressers subjects (Fast progressers are defined as participants with a decreased eGFR value of 10 ml/min/1.73m²or more within 12 months. Slow progressers are defined as participants with a maximal eGFR decrease of 9.9 ml/min/1.73m²within 12 months - ESRD - mortality Source data will be assessed at Baseline Visit and at the 12-month follow-up Visit and includes the paper-based worksheets, control scheme results and laboratory results. | — |
Countries
Austria
Contacts
Public ContactElisabeth Platzer
Universitätsklinikum für Innere Medizin, Klinische Abteilung für Nephrologie
Outcome results
None listed