Clinical trial NCT06447038: Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).
Official title: Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Kidney Disease (CKD)
Keywords: Epidemiology.
Chronic kidney disease.
Primary care.
Cardiovascular risk factors.
Lead sponsor: Hospital Universitario de Burgos
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population of the city of Burgos, Spain who go to their primary doctor.

Brief summary: Chronic kidney disease (CKD) is a significant public health problem worldwide, affecting more than 10% of the Spanish population. Early detection is considered a top healthcare priority to establish strategies for preventing progression to more advanced stages of the disease and its complications. Additionally, CKD is associated with high comorbidity, poor prognosis, and substantial resource consumption within the healthcare system. In this context, albuminuria may be a more sensitive marker of CKD than reduced glomerular filtration rate (GFR), and it is also considered an indicator of not only renal damage but also \&#34;systemic damage\&#34; (generalized endothelial dysfunction, arterial remodeling, and increased cardiovascular risk) beyond the kidney. Furthermore, the reduction of proteinuria/albuminuria is clearly associated with a slower progression of CKD, making its reduction a therapeutic goal as well. Given this importance, this protocol aims to determine the urine albumin/creatinine ratio in all patients over 18 years old who visit their primary care physician in the province of Burgos, Spain, and require a blood test related to their reason for consultation.

Detailed description: This is a protocol in which we seek to identify those patients with alterations incipient renal failure by determining the albumin/creatinine ratio in urine, test that is currently performed routinely in different groups of patients. By For this reason, the implementation of the non-dialysis objective protocol hopes to be implemented standardized form in patients who go to their primary attention doctor in the province of Burgos to later be extended to the entire Castilla y Leon community.

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Eligibility criteria: Inclusion Criteria:

* Minimum age 18 years

Exclusion Criteria:

* Age less than 18 years

Primary outcomes:
measure: Albumin creatinine ratio.
timeFrame: 01/02/2024 al 01/12/2024
Secondary outcomes:
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Maria J Izquierdo
Study officials:
affiliation: HUBU
name: Maria J Izquierdo Ortiz, Doctor
role: STUDY_DIRECTOR
affiliation: HUBU
name: Emilio J Gonzalez Parra, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: HUBU
name: Sebastian Mas Fontao, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: HUBU
name: Maria Martin Palencia, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: HUBU
name: Didier Sanchez, Doctor
role: STUDY_DIRECTOR
References:
citation: Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23.