Health Trials

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

ConditionsDialysisCritically Ill Acute Kidney InjuryRenal Replacement Therapy for Acute Kidney Injury in ICUAcute Kidney InjuryRenal Replacement TherapyAKI
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Critically ill patients with AKI requiring RRT in Latin American countries

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Acute kidney injury patients requiring renal replacement therapy

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Vantive Health LLC

Collaborator

Source ClinicalTrials.gov
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