Predicting Worsening Acute Kidney Injury With a Water-Pill (Furosemide) Test and Blood Markers in Patients With Low Albumin

Summary

The goal of this clinical trial is to learn if serum biomarkers can better predict worsening of acute kidney injury (AKI) compared to the Furosemide Stress Test (FST) in adult patients with low albumin levels (hypoalbuminemia) admitted to an intensive care unit (ICU). The main questions it aims to answer are:

Can serum biomarkers predict progression to severe AKI (stage 3) better than the Furosemide Stress Test in patients with low albumin levels? Is there a relationship between serum biomarkers levels and serum albumin levels in these patients?

Researchers will compare serum biomarkers levels and FST results to see which test more accurately identifies patients at risk of developing severe AKI.

Participants will:

Provide a sample for serum biomarkers measurement at study entry Receive a single intravenous dose of furosemide (a diuretic medication) to assess kidney function Have their urine output monitored for 6 hours after the furosemide dose Be followed for 15 days to track kidney function, need for dialysis, and survival

Conditions

• Acute Kidney Injury
• Hypoalbuminemia

Interventions

DIAGNOSTIC_TEST

Furosemide Stress Test

Single intravenous bolus of furosemide administered at 1 mg/kg in patients with no prior exposure to loop diuretics within the previous 7 days, or 1.5 mg/kg in those with such prior exposure. Urine output was measured hourly for 6 hours post-administration. Patients producing ≥200 mL at 2 hours were classified as responders; those producing \<200 mL as non-responders. The test was used as a diagnostic tool to assess tubular function, not as a therapeutic intervention.

DIAGNOSTIC_TEST

Serum Biomarkers and NGAL

Single serum biomarkers and NGAL measurement obtained at enrollment from a urine sample collected via Foley catheter. Samples were analyzed using a commercially available immunofluorescence assay (NGAL Fast Test Kit, Getein Biotech, Inc., China), immediately cooled to 4°C, aliquoted, and stored at -80°C until batch analysis. Used as a diagnostic biomarker of tubular injury, independent of albumin-mediated transport, to predict progression to KDIGO stage 3 AKI in patients with hypoalbuminemia.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon

  collaborator OTHER

• Maithe Caroline Inacio

  lead OTHER

Principal Investigators

• Lilia M Rizo-Topete, M.D. · Universidad Autónoma de Nuevo Leon - Hospital Universitario "Dr. José Eleuterio González"

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-04

Primary Completion

2024-12-10

Completion

2024-12-10

Countries

• Mexico

Study Locations