Design and methodology of the Aging Nephropathy Study (AGNES): a prospective cohort study of elderly patients with chronic kidney disease

BMC Nephrology

Giovani GN. Santos¹  Rosilene M. Elias²  Cicero Italo L. Bezerra²  Luana Cristina A. Silva²  Julia C. Lauar²  Roberto Zatz³  Rosa M. A. Moysés³  Irene L. Noronha⁴  Carla M. Avesani⁵  Bengt Lindholm⁵  Peter Stenvinkel⁵  Wilson Jacob-Filho⁶  Venceslau A. Coelho⁶ 

[1] Division of Geriatrics, Hospital das Clinicas HCFMUSP, Sao Paulo, Brazil;Division of Nephrology, Hospital das Clinicas HCFMUSP, Sao Paulo, Brazil;Division of Nephrology, Hospital das Clinicas HCFMUSP, Sao Paulo, Brazil;LIM 16, Division of Nephrology, Faculdade de Medicina Universidade de Sao Paulo, São Paulo, Brazil;Division of Nephrology, Hospital das Clinicas HCFMUSP, Sao Paulo, Brazil;LIM 29, Division of Nephrology, Faculdade de Medicina Universidade de Sao Paulo, São Paulo, Brazil;Division of Renal Medicine and Baxter Novum, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden;LIM 66, Division of Geriatrics, Faculdade de Medicina Universidade de Sao Paulo, Sao Paulo, Brazil;Division of Geriatrics, Hospital das Clinicas HCFMUSP, Sao Paulo, Brazil;

关键词: End stage renal disease;    Dialysis;    Mortality;    Renal replacement therapy;    Fragility;    Sleep;    Cognition;   

DOI  :  10.1186/s12882-020-02116-w

来源: Springer

【 摘 要 】

BackgroundRenal replacement therapy (RRT) is usually indicated for patients with chronic kidney disease (CKD) with glomerular filtration rate below 10 ml/ml/min/1.73m2. However, the need for RRT and timing of dialysis initiation are debatable for patients aged 70 years or older. We here describe the study design and methodology of the Aging Nephropathy Study (AGNES) protocol that aims at evaluating to what extent geriatric-related conditions such as frailty, cognitive dysfunction, and presence of comorbidities have an impact on survival and RRT initiation in this group of patients. In this manuscript we provide detailed information about the AGNES study design and methodology.MethodsAGNES is a prospective observational cohort that aim to investigate clinical, biochemical and demographic factors associated with RRT initiation and mortality of patients with CKD stage 4 or 5 who are aged 70 years and older. We plan to include 200 patients over 5 years. Clinically stable outpatients on conservative management for at least 6 months will be recruited from the Nephrogeriatric Clinic at the Hospital das Clinicas da Universidade de Sao Paulo, Brazil. Eligible patients are submitted to a full clinical examination, geriatric assessment, and blood test at baseline. Following the baseline visit the patients are being monitored during an observational follow up period of at least 12 months during which patients will be contacted in the clinic at their regular follow up or by phone until either RRT initiation or death occurs. This cohort includes evaluation of cognition by the education-adjusted 10-point Cognitive Screener (10-CS), frailty by Fried index score, a complete nutritional assessment (by body composition assessment, global subjective assessment and dietary intake), comorbidities by Charlson comorbidity index and biochemical markers including FGF-23 and Klotho.DiscussionThe AGNES cohort, a real-world study of current clinical practice in elderly patients with advanced CKD prior to dialysis initiation, will shed light into progression of CKD and its complications, indications of RRT and factors determining survival. This investigation will elucidate to what extent geriatric conditions, nutritional status and clinical factors are associated with survival, quality of life and RRT initiation in elderly CKD patients not yet on dialysis.Trial registrationRegistered on ClinicalTrials.gov on 18 October 2019 (NCT04132492).

【 授权许可】

CC BY