Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America (LATAM-AKID)

March 11, 2026 updated by: Javier A. Neyra, University of Alabama at Birmingham

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Javier A Neyra, MD, MSCS
  • Phone Number: 205-975-2021
  • Email: jneyra@uabmc.edu

Study Contact Backup

Study Locations

  • Bolivia
      • Cochabamba, Bolivia
        • Recruiting
        • Hospital Obrero No 2
        • Contact:
  • Brazil
      • Bahia, Brazil
        • Not yet recruiting
        • Ana Nery Hospital
        • Contact:
      • Porto Alegre, Brazil
        • Not yet recruiting
        • Hospital Sao Lucas Da Pucrs
        • Contact:
      • São Paulo, Brazil
        • Not yet recruiting
        • Hospital das Clínicas da Universidade de São Paulo
        • Contact:
  • Chile
      • Talcahuano, Chile
        • Not yet recruiting
        • Hospital Las Higueras
        • Contact:
  • Colombia
      • Bogotá, Colombia
        • Recruiting
        • Fundacion Cardioinfantil
        • Contact:
      • Popayán, Colombia
  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • Recruiting
        • Hospital General de la Plaza de la Salud
        • Contact:
  • Ecuador
      • Quito, Ecuador
        • Not yet recruiting
        • DIALNEF
        • Contact:
  • Guatemala
      • Guatemala City, Guatemala
        • Not yet recruiting
        • Instituto Guatemalteco de Seguridad Social
        • Contact:
  • Mexico
      • Guadalajara, Mexico
        • Recruiting
        • Hospital Civil de Guadalajara
        • Contact:
      • Mexico City, Mexico
        • Recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:
      • Mexico City, Mexico
        • Not yet recruiting
        • Hospital General de México Dr Eduardo Liceaga
        • Contact:
      • Monterrey, Mexico
        • Recruiting
        • Hospital Universitario "José Eleuterio González"
        • Contact:
  • Peru
      • Lima, Peru
        • Recruiting
        • Hospital Nacional Arzobispo Loayza
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients with AKI requiring RRT in Latin American countries

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: From enrollment to hospital discharge or 90 days (whichever occurs first)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU mortality
Time Frame: From enrollment to ICU discharge or 90 days (whichever occurs first)
The variable is coded as 1 = deceased and 0 = alive by the time of ICU discharge
From enrollment to ICU discharge or 90 days (whichever occurs first)
Length of stay in the ICU
Time Frame: From ICU admission to death or ICU discharge (truncated at 90 days)
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.
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)
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.
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)

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.
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

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.
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)
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.
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
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.
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)
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).
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)
These include infections associated with RRT. Events include catheter-related bloodstream infections, catheter insertion-site infections, and secondary peritonitis.
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)
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).
RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)
90-day follow-up mortality
Time Frame: From enrollment to 90-days post-ICU admission follow-up
The variable is coded as 1 = deceased and 0 = alive by the time of 90-day follow-up
From enrollment to 90-days post-ICU admission follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Vantive Health LLC

Investigators

  • Principal Investigator: Javier A Neyra, MD, MSCS, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Actual)

December 3, 2025

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300013633
  • IIR from Vantive (Other Grant/Funding Number: Vantive)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on AKI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe