Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America

Обзор

This is an international, multicenter, observational study aimed at investigating acute kidney injury requiring renal replacement therapy (AKI-RRT) in Latin American countries. The main questions this study aims to answer are: * What is the epidemiology, outcomes, and processes of care for patients with AKI-RRT in Latin America? * How do outcomes differ across different countries in Latin America? * What factors (demographics, clinical, socioeconomic) influence outcomes in patients with AKI-RRT in Latin America? The main aims of this study are to: * Establish a comprehensive database containing clinical, laboratory, treatment, process, and outcome data of patients with AKI-RRT in Latin America * Describe current epidemiology of AKI-RRT in Latin America * Compare processes of care and outcomes across different countries in Latin America * Provide data resources to facilitate and promote clinical research in AKI-RRT

Первичные конечные точки

• In-hospital mortality [Срок оценки: From enrollment to hospital discharge or 90 days (whichever occurs first)]

Вторичные конечные точки (11)

• ICU mortality [Срок оценки: From enrollment to ICU discharge or 90 days (whichever occurs first)]
• 90-day follow-up mortality [Срок оценки: From enrollment to 90-days post-ICU admission follow-up]
• Length of stay in the ICU [Срок оценки: From ICU admission to death or ICU discharge (truncated at 90 days)]
• Length of stay in the hospital [Срок оценки: From hospital admission to death or hospital discharge (truncated at 90 days)]
• Renal function recovery at hospital discharge [Срок оценки: From enrollment to hospital discharge or 90 days (whichever occurs first)]
• Renal function recovery at follow-up [Срок оценки: From enrollment to 90-days post-ICU admission follow-up]
• RRT dependence at hospital discharge [Срок оценки: From RRT initiation to hospital discharge or 90 days (whichever occurs first)]
• RRT dependence at follow-up [Срок оценки: From RRT initiation (day 0) to 90-days post-ICU admission follow-up]
• Anticoagulation-related complications associated with RRT [Срок оценки: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)]
• Infectious complications associated with RRT [Срок оценки: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)]
• RRT-related procedural complications [Срок оценки: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)]

Критерии участия

Критерии включения

• Adult patient (≥18) admitted to the ICU
• First ICU admission during current hospitalization
• Diagnosis of acute kidney injury stage 3 according to KDIGO guidelines
• RRT initiated no earlier than 3 days before or no later than 7 days after ICU admission

Критерии исключения

• Transfer from outside hospital with ongoing RRT
• RRT exposure of less than 2 days (if CRRT or PD was provided) or less than 2 HD/SLED sessions
• Kidney failure (ESRD) patients on maintenance dialysis
• Kidney transplant recipients
• Previous or new diagnosis of glomerulonephritis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Мексика · 4 центра

• Hospital Civil de Guadalajara — Guadalajara
• Hospital General de México Dr Eduardo Liceaga — Mexico City
• Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán — Mexico City
• Hospital Universitario "José Eleuterio González" — Monterrey

Бразилия · 3 центра

• Ana Nery Hospital — Bahia
• Hospital Sao Lucas da PUCRS — Porto Alegre
• Hospital das Clínicas da Universidade de São Paulo — São Paulo

Колумбия · 2 центра

• Fundación Cardioinfantil — Bogotá
• Hospital San Jose de Popayan — Popayán

Bolivia · 1 центр

• Hospital Obrero No 2 — Cochabamba

Чили · 1 центр

• Hospital Las Higueras — Talcahuano

Dominican Republic · 1 центр

• Hospital General de la Plaza de la Salud — Santo Domingo

Ecuador · 1 центр

• DIALNEF — Quito

Guatemala · 1 центр

• Instituto Guatemalteco de Seguridad Social — Guatemala City

Перу · 1 центр

• Hospital Nacional Arzobispo Loayza — Lima

Публикации

• Lombardi R, Rosa-Diez G, Ferreiro A, Greloni G, Yu L, Younes-Ibrahim M, Burdmann EA; Acute Kidney Injury Committee of the Latin American Society of Nephrology and Hypertension Working Group. Acute kidney injury in Latin America: a view on renal replacement therapy resources. Nephrol Dial Transplant. 2014 Jul;29(7):1369-76. doi: 10.1093/ndt/gfu078. Epub 2014 Apr 16. PMID 24744281
• Bello AK, McIsaac M, Okpechi IG, Johnson DW, Jha V, Harris DCH, Saad S, Zaidi D, Osman MA, Ye F, Lunney M, Jindal K, Klarenbach S, Kalantar-Zadeh K, Kovesdy CP, Parekh RS, Prasad B, Khan M, Riaz P, Tonelli M, Wolf M, Levin A; ISN North America and the Caribbean Regional Board. International Society of Nephrology Global Kidney Health Atlas: structures, organization, and services for the management PMID 33981472
• Wainstein M, Nlandu Y, Viecelli A, Neyra JA, Arruebo S, Caskey FJ, Damster S, Donner JA, Jha V, Levin A, Nangaku M, Saad S, Tonelli M, Ye F, Okpechi IG, Bello AK, Johnson DW, Cerda J. A global snapshot on health systems capacity for detection, monitoring, and management of acute kidney injury: A multinational study from the ISN-GKHA. PLOS Glob Public Health. 2024 Oct 15;4(10):e0003823. doi: 10.137 PMID 39405323
• Mehta RL, Burdmann EA, Cerda J, Feehally J, Finkelstein F, Garcia-Garcia G, Godin M, Jha V, Lameire NH, Levin NW, Lewington A, Lombardi R, Macedo E, Rocco M, Aronoff-Spencer E, Tonelli M, Zhang J, Remuzzi G. Recognition and management of acute kidney injury in the International Society of Nephrology 0by25 Global Snapshot: a multinational cross-sectional study. Lancet. 2016 May 14;387(10032):2017-2 PMID 27086173
• Rehman AU, Renzi S, Castro DAB, Cervantes L, Clavero R, Davidson B, Farias MR, Girard VC, Claure-Del Granado R, Ramirez-Guerrero G, Jimenez D, Leon Rabanal CP, Molano Trivino A, Reis T, Rizo-Topete L, Vega-Vega O, Viecelli AK, Kamile Singer Wallbach-Massai K, Wainstein M, Karam S, Neyra JA. Barriers and Facilitators to Renal Replacement Therapy for Acute Kidney Injury in Latin America: Insights Fr PMID 40814609
• Ponce D, Balbi A. Acute kidney injury: risk factors and management challenges in developing countries. Int J Nephrol Renovasc Dis. 2016 Aug 22;9:193-200. doi: 10.2147/IJNRD.S104209. eCollection 2016. PMID 27578995
• Susantitaphong P, Cruz DN, Cerda J, Abulfaraj M, Alqahtani F, Koulouridis I, Jaber BL; Acute Kidney Injury Advisory Group of the American Society of Nephrology. World incidence of AKI: a meta-analysis. Clin J Am Soc Nephrol. 2013 Sep;8(9):1482-93. doi: 10.2215/CJN.00710113. Epub 2013 Jun 6. PMID 23744003
• Rehman AU, Nombera-Aznaran N, Renzi S, Ghazi L, Tolwani AJ, Molano Trivino A, Reis T, Vega-Vega O, Rizo-Topete L, Claure-Del Granado R, Neyra JA. LATAM-AKID registry: an international multicentre, observational study of acute kidney injury requiring dialysis in Latin America. BMJ Open. 2026 Jun 24;16(6):e115953. doi: 10.1136/bmjopen-2025-115953. PMID 42342404

Идентификаторы

NCT: NCT07262320 · IRB-300013633 · IIR from Vantive

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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