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End-stage renal disease (ESRD) patients on hemodialysis are a vulnerable population with specific requirements and increased adverse clinical outcomes as compared to the general population. Initiatives such as the DOPPS initiative have created prospective cohorts of these populations worldwide, and they recommend performing local cohorts based on their protocols to achieve local data, which may be comparable to international data. Currently, only a few prospective cohorts in Latin America collect individual patient data and patient samples, where there is little participation in the DOPPS initiative for ESRD patients. Our objective is to perform a prospective cohort of ESRD patients on hemodialysis in Chile, which fulfills the requirements of the DOPPS initiative.
National multicenter prospective cohort of ESRD on hemodialysis in Chile (DEW-HD study, Figure 1). The study aims to recruit at least 2,000 patients between 2023 and 2025 (approximately 10% of total ESRD on hemodialysis in Chile). We will include patients above 18 years admitted to chronic hemodialysis, independent of clinical data, modality, dialysis frequency, or additional hemodialysis characteristics. We will exclude patients admitted to palliative hemodialysis or those who refused to participate. The study design is based on the DOPPS protocols for prospective studies in hemodialysis patients. After signed consent, all patients will have a collection of demographical, clinical, laboratory, and hemodialysis data, plus evaluation of quality-of-life surveys and similar. We will obtain blood samples for storage of plasma and DNA from peripheral blood mononuclear cells, which will be stored in a biobank. All patients will be followed to determine the development of relevant clinical outcomes: major cardiovascular events (MACE), severe infection, any-cause death, renal transplantation, change to peritoneal dialysis, or dialysis withdrawal. The primary objective is to determine associations between observed variations in practice patterns and patient-level outcomes. We evaluated the previous adjusted mortality ratio (AMR) in 2022 to estimate statistical power. The Institutional Ethics Committee has approved this study and has international institutions' support for the cohort's design and implementation.
As of October 2023, we have recruited 832 patients from 8 hemodialysis centers in 4 regions of Chile. Female: 56%, Age: 65,4 ± 13,5 years. Diabetes: 39%. Hypertension: 79%. Vascular access: Arteriovenous fistula: 67% Tunneled catheter: 29%. Hemodialysis vintage: 27 [19-49] months. Adjusted mortality ratio per year: 9%. Clinical follow-up will initiate in January 2024, with a minimum follow-up of 5 years after recruitment.
This is the first multicenter prospective cohort of ESRD patients on hemodialysis that will fulfill the DOPPS protocols in Chile and Latin America. This study will provide relevant information on this group of patients that will be useful to improve the management and clinical outcomes of this population in Latin America.
Study supported by FONDECYT Regular 1221571.