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

NCT07688733 | Completed

• 2 other identifiers: NF22-00003U1111-1342-1576
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Hypoalbuminemia; Acute Kidney Injury

Keywords

AKI Progression; Furosemide Stress Test; Hypoalbuminemia; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Progression to KDIGO Stage 3 Acute Kidney Injury

  Proportion of patients who progressed from KDIGO stage 1-2 to stage 3 AKI, assessed by changes in serum creatinine and/or urine output per KDIGO 2012 criteria. Predictive performance evaluated by AUC-ROC for both uNGAL and Furosemide Stress Test.

  15 days from enrollment

Secondary Outcomes (2)

• Need for Renal Replacement Therapy

  15 days from enrollment

• 15-Day Mortality

  15 days from enrollment

Study Arms (1)

AKI with Hypoalbuminemia

EXPERIMENTAL

Adult ICU patients with KDIGO stage 1-2 AKI and serum albumin \<3 g/dL. All participants underwent urinary NGAL measurement followed by a standardized Furosemide Stress Test (furosemide 1-1.5 mg/kg IV). Outcomes assessed over 15 days: progression to KDIGO stage 3, need for renal replacement therapy, and mortality.

Diagnostic Test: Furosemide Stress Test; Diagnostic Test: Serum Biomarkers and NGAL

Interventions

Furosemide Stress Test DIAGNOSTIC_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.

AKI with Hypoalbuminemia

Serum Biomarkers and NGAL DIAGNOSTIC_TEST

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.

AKI with Hypoalbuminemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Serum albumin \< 3 g/dL (hypoalbuminemia)
• AKI diagnosed per KDIGO 2012 criteria, stage 1 or 2
• Adequate fluid resuscitation at discretion of treating nephrologist
• Cellular casts in urinary sediment (George Washington Urine Sediment Score \> 2) or fractional excretion of sodium (FENa) \> 1%
• Foley catheter in place
• Written informed consent obtained

You may not qualify if:

• Age under 18 years
• Pregnancy
• Obstructive urinary pathology
• Active bleeding
• Allergy or hypersensitivity to loop diuretics
• AKI stage 3 (KDIGO) at enrollment
• Inadequate fluid resuscitation prior to the stress test
• Known chronic kidney disease with eGFR \< 30 mL/min/1.73 m² (CKD-EPI equation)

Sponsors & Collaborators

• Maithe Caroline Inacio: lead
• Universidad Autonoma de Nuevo Leon: collaborator

Study Sites (1)

Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Acute Kidney Injury; Hypoalbuminemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Lilia M Rizo-Topete, M.D.

  Universidad Autónoma de Nuevo Leon - Hospital Universitario "Dr. José Eleuterio González"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Model Details: Single-group quasi-experimental study; all eligible patients received both the Furosemide Stress Test and biomarkers measurement without randomization or comparator arm.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 7, 2026
• Study Start: June 4, 2022
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)