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

NCT07262320 | Recruiting

• 2 other identifiers: IRB-300013633IIR from Vantive
• Study Type: observational
• Target: 1,000
• Locations: 9 countries
• Sites: 15

Brief Summary

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

Conditions

Dialysis; Critically Ill Acute Kidney Injury; Renal Replacement Therapy for Acute Kidney Injury in ICU; Acute Kidney Injury; Renal Replacement Therapy; AKI

Keywords

AKI; ICU; RRT; Latin America; acute kidney injury; renal replacement therapy; intensive care unit; dialysis

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  The variable is coded as 1 = deceased and 0 = alive by the time of hospital discharge

  From enrollment to hospital discharge or 90 days (whichever occurs first)

Secondary Outcomes (11)

• ICU mortality

  From enrollment to ICU discharge or 90 days (whichever occurs first)

• 90-day follow-up mortality

  From enrollment to 90-days post-ICU admission follow-up

• Length of stay in the ICU

  From ICU admission to death or ICU discharge (truncated at 90 days)

• Length of stay in the hospital

  From hospital admission to death or hospital discharge (truncated at 90 days)

• Renal function recovery at hospital discharge

  From enrollment to hospital discharge or 90 days (whichever occurs first)

Study Arms (1)

Acute kidney injury patients requiring renal replacement therapy

Critically ill adult patients with acute kidney injury undergoing any form of renal replacement therapy in Latin American hospitals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients with AKI requiring RRT in Latin American countries

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Vantive Health LLC: collaborator

Study Sites (15)

Hospital Obrero No 2

Cochabamba, Bolivia

RECRUITING

Ana Nery Hospital

Bahia, Brazil

NOT YET RECRUITING

Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

NOT YET RECRUITING

Hospital das Clínicas da Universidade de São Paulo

São Paulo, Brazil

NOT YET RECRUITING

Hospital Las Higueras

Talcahuano, Chile

NOT YET RECRUITING

Fundación Cardioinfantil

Bogotá, Colombia

RECRUITING

Hospital San Jose de Popayan

Popayán, Colombia

RECRUITING

Hospital General de la Plaza de la Salud

Santo Domingo, Dominican Republic

RECRUITING

DIALNEF

Quito, Ecuador

NOT YET RECRUITING

Instituto Guatemalteco de Seguridad Social

Guatemala City, Guatemala

NOT YET RECRUITING

Hospital Civil de Guadalajara

Guadalajara, Mexico

RECRUITING

Hospital General de México Dr Eduardo Liceaga

Mexico City, Mexico

NOT YET RECRUITING

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico

RECRUITING

Hospital Universitario "José Eleuterio González"

Monterrey, Mexico

RECRUITING

Hospital Nacional Arzobispo Loayza

Lima, Peru

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 of kidney failure in North America and the Caribbean. Kidney Int Suppl (2011). 2021 May;11(2):e66-e76. doi: 10.1016/j.kisu.2021.01.001. Epub 2021 Apr 12.

  PMID: 33981472 BACKGROUND

• 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: 10.1371/journal.pgph.0003823. eCollection 2024.

  PMID: 39405323 BACKGROUND

• 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):2017-25. doi: 10.1016/S0140-6736(16)30240-9. Epub 2016 Apr 13.

  PMID: 27086173 BACKGROUND

• 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 From an Expert Roundtable. Kidney Int Rep. 2025 Jun 19;10(8):2515-2519. doi: 10.1016/j.ekir.2025.06.030. eCollection 2025 Aug. No abstract available.

  PMID: 40814609 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Javier A Neyra, MD, MSCS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier A Neyra, MD, MSCS

CONTACT

205-975-2021; jneyra@uabmc.edu

Patricia J Busta Flores

CONTACT

205-975-2251; pjbustaflores@uabmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 3, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1); ME (4); BO (1); CL (1); GU (1); EC (1); PE (1); CO (2); BR (3)