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Clinical Trials/NCT07262320
NCT07262320
Recruiting
Not Applicable

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

University of Alabama at Birmingham17 sites in 9 countries1,000 target enrollmentStarted: March 1, 2026Last updated:
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Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
1,000
Locations
17
Primary Endpoint
In-hospital mortality
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Length of stay in the ICU(From ICU admission to death or ICU discharge (truncated at 90 days))
  • RRT dependence at follow-up(From RRT initiation (day 0) to 90-days post-ICU admission follow-up)
  • RRT dependence at hospital discharge(From RRT initiation to hospital discharge or 90 days (whichever occurs first))
  • Infectious complications associated with RRT(RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first))
  • 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)
  • Anticoagulation-related complications associated with RRT(RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first))
  • Length of stay in the hospital(From hospital admission to death or hospital discharge (truncated at 90 days))
  • Renal function recovery at follow-up(From enrollment to 90-days post-ICU admission follow-up)
  • RRT-related procedural complications(RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first))
  • Renal function recovery at hospital discharge(From enrollment to hospital discharge or 90 days (whichever occurs first))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Javier A. Neyra

Professor of Medicine

University of Alabama at Birmingham

Study Sites (17)

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