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

NCT ID: NCT07262320

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-03-01

Study Completion Date

2027-06-30

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vantive Health LLC

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Javier A. Neyra

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Javier A Neyra, MD, MSCS

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Hospital Obrero No 2

Cochabamba, , Bolivia

Site Status

Ana Nery Hospital

Bahia, , Brazil

Site Status

Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

Site Status

Hospital das Clínicas da Universidade de São Paulo

São Paulo, , Brazil

Site Status

Hospital Las Higueras

Talcahuano, , Chile

Site Status

Fundación Cardioinfantil

Bogotá, , Colombia

Site Status

Hospital San Jose de Popayan

Popayán, , Colombia

Site Status

DIALNEF

Quito, , Ecuador

Site Status

Instituto Guatemalteco de Seguridad Social

Guatemala City, , Guatemala

Site Status

Hospital Civil de Guadalajara

Guadalajara, , Mexico

Site Status

Hospital General de México Dr Eduardo Liceaga

Mexico City, , Mexico

Site Status

Hospital Universitario "José Eleuterio González"

Monterrey, , Mexico

Site Status

Hospital Nacional Arzobispo Loayza

Lima, , Peru

Site Status

Countries

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Bolivia Brazil Chile Colombia Ecuador Guatemala Mexico Peru

Central Contacts

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Javier A Neyra, MD, MSCS

Role: CONTACT

205-975-2021

Patricia J Busta Flores

Role: CONTACT

205-975-2251

Facility Contacts

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Rolando Claure-Del Granado

Role: primary

+591 (4) 4240022

Fernanda P Martin Tapioca

Role: primary

+55 71988502249

Daniele Cristovao Escouto

Role: primary

+55 5199624149

Camila Eleuterio Rodrigues

Role: primary

+ 55 11 94728 4006

Gonzalo Ramírez Guerrero

Role: primary

+56 981746173

Alejandra Molano- Triviño

Role: primary

+57 3453449865

David Ballesteros

Role: primary

+57 3105542506

Dario Jimenez

Role: primary

+59 3992773176

Regina Sosa

Role: primary

+502 57311591

Jonathan Chavez

Role: primary

+52 3313299609

Pablo Galindo

Role: primary

+52 5551564682

Lilia Rizo-Topete

Role: primary

+52 8180297718

Yanissa Venegas Justiniano

Role: primary

+51 949709432

References

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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.

Reference Type BACKGROUND
PMID: 33981472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39405323 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27086173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40814609 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27578995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23744003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24744281 (View on PubMed)

Other Identifiers

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IIR from Vantive

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300013633

Identifier Type: -

Identifier Source: org_study_id

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