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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1342-1576 | Other Identifier | International Clinical Trials Registry Platform (ICTRP) |
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| Name | Class |
|---|---|
| Universidad Autonoma de Nuevo Leon | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Renal Replacement Therapy | 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 days from enrollment |
| 15-Day Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lilia M Rizo-Topete, M.D. | Universidad Autónoma de Nuevo Leon - Hospital Universitario "Dr. José Eleuterio González" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario "Dr. José Eleuterio González" | Monterrey | Nuevo León | 64460 | Mexico |
Individual participant data will not be shared publicly due to patient privacy regulations and institutional policies. Data are available from the corresponding author upon reasonable request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol translated to English | Sep 1, 2024 | Jun 24, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Translated to English | Sep 1, 2024 | Jun 24, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D034141 | Hypoalbuminemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Single-group quasi-experimental study; all eligible patients received both the Furosemide Stress Test and biomarkers measurement without randomization or comparator arm.
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| 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. |
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All-cause mortality within the first 15 days of enrollment, recorded through medical record review. |
| 15 days from enrollment |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007019 | Hypoproteinemia |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |