DialysisLATAM-AKIDNCT07262320
Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America
An observational study of Dialysis and Critically Ill Acute Kidney Injury, run by University of Alabama at Birmingham at 15 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis, Critically Ill Acute Kidney Injury, Renal Replacement Therapy for Acute Kidney Injury in ICU
- How many people
- 1,000 participants
- Where
- 15 sitesin 9 countries
- Study dates
- 1 Mar 2026to 30 Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients with AKI requiring RRT in Latin American countries
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 9 countries
Mexico4 sites, 4 recruiting
- Recruiting
Hospital Civil de Guadalajara
Guadalajara
Jonathan Chavez, +52 3313299609, jonarchi_10@hotmail.com
- Not yet recruiting
Hospital General de México Dr Eduardo Liceaga
Mexico City
Pablo Galindo, +52 5551564682, galindozip@gmail.com
- Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City
Olynka Vega, +52 55 48039428., olynkavega@gmail.com
- Recruiting
Hospital Universitario "José Eleuterio González"
Monterrey
Lilia Rizo-Topete, +52 8180297718, dra.liliarizo@gmail.com
Brazil3 sites, 3 recruiting
- Not yet recruiting
Ana Nery Hospital
Bahia
Fernanda P Martin Tapioca, +55 71988502249, fernandapmartin@hotmail.com
- Not yet recruiting
Hospital Sao Lucas da PUCRS
Porto Alegre
Daniele Cristovao Escouto, +55 5199624149, daniele.escouto@pucrs.br
- Not yet recruiting
Hospital das Clínicas da Universidade de São Paulo
São Paulo
Camila Eleuterio Rodrigues, + 55 11 94728 4006, camila.eleuterio@hc.fm.usp.br
Colombia2 sites, 2 recruiting
- Recruiting
Fundación Cardioinfantil
Bogotá
Alejandra Molano- Triviño, +57 3453449865, alepatrimoltri@gmail.com
- Recruiting
Hospital San Jose de Popayan
Popayán
David Ballesteros, +57 3105542506, david.ballesteros.c@gmail.com
Bolivia1 site, 1 recruiting
- Recruiting
Hospital Obrero No 2
Cochabamba
Rolando Claure-Del Granado, +591 (4) 4240022, rclaure@yahoo.com
Chile1 site, 1 recruiting
- Not yet recruiting
Hospital Las Higueras
Talcahuano
Gonzalo Ramírez Guerrero, +56 981746173, ramirezguerrero.g@gmail.com
Dominican Republic1 site, 1 recruiting
- Recruiting
Hospital General de la Plaza de la Salud
Santo Domingo
Elin Guzman, 829-571-1313, dr.elinguzman@gmail.com
Ecuador1 site, 1 recruiting
- Not yet recruiting
DIALNEF
Quito
Dario Jimenez, +59 3992773176, dxjimenezmd@gmail.com
Guatemala1 site, 1 recruiting
- Not yet recruiting
Instituto Guatemalteco de Seguridad Social
Guatemala City
Regina Sosa, +502 57311591, sosaregina@yahoo.com
Peru1 site, 1 recruiting
- Recruiting
Hospital Nacional Arzobispo Loayza
Lima
Yanissa Venegas Justiniano, +51 949709432, joanna.venegas.j@upch.pe
About this study
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?
Read more
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
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
The variable is coded as 1 = deceased and 0 = alive by the time of hospital discharge
Measured: From enrollment to hospital discharge or 90 days (whichever occurs first)
Secondary outcomes (11)
ICU mortality
The variable is coded as 1 = deceased and 0 = alive by the time of ICU discharge
Measured: From enrollment to ICU discharge or 90 days (whichever occurs first)
90-day follow-up mortality
The variable is coded as 1 = deceased and 0 = alive by the time of 90-day follow-up
Measured: From enrollment to 90-days post-ICU admission follow-up
Length of stay in the ICU
Length of stay will be calculated as the total number of full days between admission and discharge from the ICU. A calendar day will be counted toward the total only if the duration of stay on that day is two hours or longer.
Measured: From ICU admission to death or ICU discharge (truncated at 90 days)
Length of stay in the hospital
Length of stay will be calculated as the total number of full days between admission and discharge from the hospital. A calendar day will be counted toward the total only if the duration of stay on that day is two hours or longer.
Measured: From hospital admission to death or hospital discharge (truncated at 90 days)
Renal function recovery at hospital discharge
Recovery will be defined as improvement in kidney function based on serum creatinine value at hospital discharge compared with baseline serum creatinine.
Baseline serum creatinine will be defined as either of the following (in order of priority) 1) Average of 3 closest outpatient values 7-365 days before index hospitalization; 2) Lowest value in the inpatient setting 7-365 days before index hospitalization; 3) Lowest value in the first 30 days during index hospitalization (not during or within 48h after RRT discontinuation).
Patients who have serum creatinine <0.3 mg/dL higher than baseline at hospital discharge will be considered to have recovered renal function.
Measured: From enrollment to hospital discharge or 90 days (whichever occurs first)
Renal function recovery at follow-up
Recovery will be defined as improvement in kidney function based of serum creatinine value at follow-up compared with baseline serum creatinine.
Baseline serum creatinine will be defined as either of the following (in order to priority) 1) Average of 3 closest outpatient values 7-365 days before index hospitalization; 2) Lowest value in the inpatient setting 7-365 days before index hospitalization; 3) Lowest value in the first 30 days during index hospitalization (not during or within 48h after RRT discontinuation).
Patients who have serum creatinine <0.3 mg/dl higher than baseline at follow-up will be considered to have recovered renal function.
Measured: From enrollment to 90-days post-ICU admission follow-up
RRT dependence at hospital discharge
Patients will be classified as RRT-dependent if they continue to require any form of RRT at discharge. Patients who no longer require RRT will be classified as RRT-independent.
Measured: From RRT initiation to hospital discharge or 90 days (whichever occurs first)
RRT dependence at follow-up
Patients will be classified as RRT-dependent if they continue to require any form of RRT at follow-up assessment. Patients who no longer require RRT will be considered RRT-independent.
Measured: From RRT initiation (day 0) to 90-days post-ICU admission follow-up
Anticoagulation-related complications associated with RRT
These include complications attributable to different types of anticoagulation (systemic unfractionated heparin, systemic low molecular weight heparin, regional citrate anticoagulation, other) used during RRT. Events include hemorrhage, heparin-induced thrombocytopenia (where relevant), citrate excess (where relevant), and citrate deficit (where relevant).
Measured: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)
Infectious complications associated with RRT
These include infections associated with RRT. Events include catheter-related bloodstream infections, catheter insertion-site infections, and secondary peritonitis.
Measured: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)
RRT-related procedural complications
Procedural or mechanical complications occurring during RRT will be identified from medical records and bedside documentation. These include catheter malfunction (e.g., kinking, disconnection, malposition, migration, catheter tip adherence to vessel wall), circuit interruptions, circuit replacements, RRT downtime (where relevant).
Measured: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DialysisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Vantive Health LLC
- Responsible party
- Principal investigator, Javier A. Neyra, University of Alabama at Birmingham
- Investigators
- Javier A Neyra, MD, MSCS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262320
- Sponsor's protocol ID
- IRB-300013633
- Other IDs
- IIR from Vantive
- Acronym
- LATAM-AKID
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24744281Bello 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.
PubMed 33981472Wainstein 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.
PubMed 39405323Mehta 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.
PubMed 27086173Rehman 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.
PubMed 40814609Ponce 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.
PubMed 27578995Susantitaphong 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.
PubMed 23744003Rehman 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.
PubMed 42342404