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RecruitingNCT07262320LATAM-AKIDUpdated Mar 12, 2026

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

An observational study in Dialysis, Critically Ill Acute Kidney Injury and Renal Replacement Therapy for Acute Kidney Injury in ICU, sponsored by University of Alabama at Birmingham. Recruiting at 15 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by University of Alabama at Birmingham · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

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

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Keywords

  • AKI
  • ICU
  • RRT
  • Latin America
  • acute kidney injury
  • renal replacement therapy
  • intensive care unit
  • dialysis
03

In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 160 across 814 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critically ill patients with AKI requiring RRT in Latin American countries

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. In-hospital mortality

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

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

Secondary outcomes

  1. ICU mortality

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

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

  2. 90-day follow-up mortality

    The variable is coded as 1 = deceased and 0 = alive by the time of 90-day follow-up

    Time frame: From enrollment to 90-days post-ICU admission follow-up

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

    Time frame: From enrollment to 90-days post-ICU admission follow-up

  7. 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.

    Time frame: From RRT initiation to hospital discharge or 90 days (whichever occurs first)

  8. 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.

    Time frame: From RRT initiation (day 0) to 90-days post-ICU admission follow-up

  9. 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).

    Time frame: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)

  10. Infectious complications associated with RRT

    These include infections associated with RRT. Events include catheter-related bloodstream infections, catheter insertion-site infections, and secondary peritonitis.

    Time frame: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)

  11. 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).

    Time frame: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)

07

Study locations

8 of 15 sites recruiting
08

References and documents

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 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 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 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: 10.1371/journal.pgph.0003823. eCollection 2024. PubMed 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):2017-25. doi: 10.1016/S0140-6736(16)30240-9. Epub 2016 Apr 13. PubMed 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 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 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. PubMed 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. PubMed 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. PubMed 42342404 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2025
First posted
Dec 3, 2025
StartActual
Mar 1, 2026
Primary completionEst.
Mar 31, 2027
CompletionEst.
Jun 30, 2027
Last update
Mar 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07262320
Collaborators
Vantive Health LLC
Responsible party
Javier A. Neyra (Professor of Medicine, University of Alabama at Birmingham) — Principal investigator
First posted
Dec 3, 2025
Start date
Mar 1, 2026
Primary completion
Mar 31, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Mar 12, 2026

Study contacts

Javier A Neyra, MD, MSCS
Contact
jneyra@uabmc.edu
205-975-2021
Patricia J Busta Flores
Contact
pjbustaflores@uabmc.edu
205-975-2251
Javier A Neyra, MD, MSCS
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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