Acute Kidney Injury, Hypoalbuminemia
Conditions
Keywords
AKI Progression, Furosemide Stress Test, Hypoalbuminemia, Biomarkers
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
Interventions
DIAGNOSTIC_TESTFurosemide 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_TESTSerum 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
Maithe Caroline Inacio
Universidad Autonoma de Nuevo Leon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single-group quasi-experimental study; all eligible patients received both the Furosemide Stress Test and biomarkers measurement without randomization or comparator arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression to KDIGO Stage 3 Acute Kidney Injury | 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
| Measure | Time frame | Description |
|---|---|---|
| Need for Renal Replacement Therapy | 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. |
| 15-Day Mortality | 15 days from enrollment | All-cause mortality within the first 15 days of enrollment, recorded through medical record review. |
Countries
Mexico
Contacts
PRINCIPAL_INVESTIGATORLilia M Rizo-Topete, M.D.
Universidad Autónoma de Nuevo Leon - Hospital Universitario "Dr. José Eleuterio González"
Outcome results
None listed