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OpenTrials
Completed

NCT Number: NCT07688733

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Nuevo León, 64460, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Progression to KDIGO Stage 3 Acute Kidney Injury

    Time frame: 15 days from enrollment

    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.

Secondary outcomes

  1. Need for Renal Replacement Therapy

    Time frame: 15 days from enrollment

    Proportion of patients requiring initiation of renal replacement therapy (intermittent hemodialysis or continuous renal replacement therapy) during the follow-up period, based on clinical criteria per the treating nephrologist.

  2. 15-Day Mortality

    Time frame: 15 days from enrollment

    All-cause mortality within the first 15 days of enrollment, recorded through medical record review.

Sponsors and collaborators

Lead sponsor

Maithe Caroline Inacio

Other

Collaborators

  • Universidad Autonoma de Nuevo Leon

Registry information

Official study title

Furosemide Stress Test and Serum Biomarkers as Predictive Markers for Progression of Acute Kidney Injury in Patients With Hypoalbuminemia

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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