Acute Kidney InjuryNCT07688733
Predicting Worsening Acute Kidney Injury With a Water-Pill (Furosemide) Test and Blood Markers in Patients With Low Albumin
A study testing Furosemide Stress Test and Serum Biomarkers and NGAL in people with Acute Kidney Injury and Hypoalbuminemia, run by Maithe Caroline Inacio at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Hypoalbuminemia
- What is being tested?
- Furosemide Stress Test and Serum Biomarkers and NGAL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteMexico
- Study dates
- 4 Jun 2022to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, Nuevo León, 64460
About this study
Official title: Furosemide Stress Test and Serum Biomarkers as Predictive Markers for Progression of Acute Kidney Injury in Patients With Hypoalbuminemia
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?
Read more
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
- Being tested
- Furosemide Stress Test, Serum Biomarkers and NGAL
- Keywords
- AKI Progression, Furosemide Stress Test, Hypoalbuminemia, Biomarkers
- Medical subject headings
- Acute Kidney Injury, Hypoalbuminemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide Stress TestDiagnostic 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 NGALDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Furosemide Stress Test; Diagnostic Test: Serum Biomarkers and NGAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days from enrollment
Secondary outcomes (2)
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.
Measured: 15 days from enrollment
15-Day Mortality
All-cause mortality within the first 15 days of enrollment, recorded through medical record review.
Measured: 15 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start4 Jun 2022
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group quasi-experimental study; all eligible patients received both the Furosemide Stress Test and biomarkers measurement without randomization or comparator arm.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maithe Caroline Inacio
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma de Nuevo Leon
- Responsible party
- Sponsor-investigator, Maithe Caroline Inacio, Universidad Autonoma de Nuevo Leon
- Investigators
- Lilia M Rizo-Topete, M.D., Principal investigator, Universidad Autónoma de Nuevo Leon - Hospital Universitario "Dr. José Eleuterio González"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688733
- Sponsor's protocol ID
- NF22-00003
- Other IDs
- U1111-1342-1576
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furosemide Stress Test and Serum Biomarkers as Predictive Markers for Progression of Acute Kidney Injury in Patients With Hypoalbuminemia
- ClinicalTrials.gov ID
- NCT07688733
- Acronym / sponsor ID
- NF22-00003
- Conditions
- Acute Kidney Injury, Hypoalbuminemia
- Keywords
- AKI Progression, Furosemide Stress Test, Hypoalbuminemia, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Maithe Caroline InacioUniversity, hospital or other
- Collaborators
- Universidad Autonoma de Nuevo Leon
- Study start
- 4 Jun 2022 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group quasi-experimental study; all eligible patients received both the Furosemide Stress Test and biomarkers measurement without randomization or comparator arm.
| Arm | Type | Receives |
|---|---|---|
| AKI with Hypoalbuminemia | Experimental | Diagnostic Test: Furosemide Stress Test, Diagnostic Test: Serum Biomarkers and NGALAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (8 listed)
- Age under 18 years
- Pregnancy
- Obstructive urinary pathology
- Active bleeding
- Allergy or hypersensitivity to loop diuretics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide Stress TestSingle 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 | AKI with Hypoalbuminemia |
| Serum Biomarkers and NGALSingle 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. | Diagnostic test | AKI with Hypoalbuminemia |
Primary outcome
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.
2 secondary outcomes
Need for Renal Replacement Therapy
Time frame: 15 days from enrollment
15-Day Mortality
Time frame: 15 days from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilia M Rizo-Topete, M.D. principal investigator
Universidad Autónoma de Nuevo Leon - Hospital Universitario "Dr. José Eleuterio González"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemide Stress Test and Serum Biomarkers and NGAL in people with Acute Kidney Injury and Hypoalbuminemia, run by Maithe Caroline Inacio at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression to KDIGO Stage 3 Acute Kidney Injury (time frame: 15 days from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.