Screening for Albuminuria at the First Line for Early Identification of CKD (SALINE)

General Practitioners Research Institute

Status: Completed

Conditions: Chronic Kidney Diseases; Albuminuria

Treatments: Diagnostic Test: Albuminuria test; Diagnostic Test: HbA1c test; Diagnostic Test: Creatinine test

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT05321095

GPRI-21004-CKD

Details and patient eligibility

About

Early detection of kidney disease

Full description

Early detection and appropriate treatment of kidney disease is important as this may prevent future cardiovascular complications and end-organ damage more effectively than intervention in more advanced stages of disease. There is a well-established relationship between albuminuria and renal- and cardiovascular disease. Elevated albuminuria has a relatively high prevalence in the general population (5-9%). The prevalence of albuminuria is even higher in high-risk patients with diabetes Mellitus, hypertension, obesity, cardiovascular disease and lipid disorders. Adequate treatment of albuminuria, preferable at early stages can prevent both cardiovascular and renal disease progression. However, scarce epidemiological data show that albuminuria measurements are only conducted in a minority of individuals and disease recognition is suboptimal, even in high-risk groups. The current study aims to evaluate if and how early identification of chronic kidney disease by targeted screening of albuminuria levels is feasible in primary care (pharmacies and general practitioners) to optimally discover and treat patients with elevated albuminuria.

Enrollment: 141 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes Mellitus (diagnosis or prescription for the disease based on the NHG guidelines)
• Adipositas (diagnosis)
• Hypertension (diagnosis or prescription for the disease based on the NHG guidelines)
• Cardiovascular disease (diagnosis, specified in protocol section 5.2.2)
• Lipid disorder (diagnosis or prescription for the disease based on the NHG guidelines)

Exclusion criteria

• Inability to understand and sign the informed consent form
• Pregnancy

Trial design

141 participants in 1 patient group

Screening

Description:

Only one group will be evaluated during the SALINE study. Everyone that meets the inclusion criteria of having a high risk for albuminuria is invited to participate. During participation, subjects are asked to collect one or more urine samples for albuminuria determination. If albuminuria is high (\>= 3,0 mg/mmol) subjects are invited for a visit. During the visit non-invasive measurements (BMI, PoC HbA1c, eGFR, blood pressure and heart rate) are taken to determine the cardiovascular risk. Furthermore, medication use is reviewed.

Treatment:

Diagnostic Test: Creatinine test

Diagnostic Test: HbA1c test

Diagnostic Test: Albuminuria test