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

Overview

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

Primary outcome measures

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

Secondary outcome measures (11)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Mexico · 4 centers

• 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

Brazil · 3 centers

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

Colombia · 2 centers

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

Bolivia · 1 center

• Hospital Obrero No 2 — Cochabamba

Chile · 1 center

• Hospital Las Higueras — Talcahuano

Dominican Republic · 1 center

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

Ecuador · 1 center

• DIALNEF — Quito

Guatemala · 1 center

• Instituto Guatemalteco de Seguridad Social — Guatemala City

Peru · 1 center

• Hospital Nacional Arzobispo Loayza — Lima

Publications

• 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

Identifiers

NCT: NCT07262320 · IRB-300013633 · IIR from Vantive

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗