Akut Kidney InjuryNCT06765031
The Role of Furosemide Stress Test in the Intensive Care Clinic
A study testing Furosemide in people with Akut Kidney Injury, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
AKI causes high mortality and morbidity, especially in critically ill patients, and prolongs the patient's stay in the intensive care unit. Due to the high morbidity and mortality associated with AKI, many researchers are studying several new biomarkers for earlier detection of AKI, determination of etiologies, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Akut Kidney Injury
- What is being tested?
- Furosemide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 31 Mar 2026
- 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
- Those who meet KDIGO AKI stage 1 and stage 2 criteria in the first 24 hours
- Those with sufficient fluid volume (CVP≥6 cmH20)
- Female and male patients over the age of 18 will be included in the study
Who cannot join
- Pregnant patients
- Hospitalization due to intoxication
- Liver or kidney transplant
- Glomerular filtration rate below 30 ml/min/1.73m2
- Active bleeding
- Patients with obstructive uropathy
Show all 13Show fewer
- Patients in need of urgent RRT (K≥6.6 meq/L, pH<7.15, pulmonary edema due to fluid overload, uremic complications)
- Patients evaluated as KDIGO AKI stage 3
- Patients who have received RRT in the last 30 days
- Patients with CKD diagnosis
- Patients with pulmonary embolism
- Hypoalbuminemia≥2.5 g/dl,
- Patients receiving cephalosporin treatment will be excluded from the sample.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, keçiören, 06010
About this study
Official title: The Role of Furosemide Stress Test in Predicting Acute Kidney Injury Progression and Need for Renal Replacement Therapy in Patients Followed in the Intensive Care Clinic
AKI causes high mortality and morbidity, especially in critically ill patients, and prolongs the patient's stay in the intensive care unit. Due to the high morbidity and mortality associated with AKI, many researchers are studying several new biomarkers for earlier detection of AKI, determination of etiologies, and prediction of outcomes. However, the use of these new biomarkers may be limited due to reimbursement issues. In addition to the therapeutic role of furosemide in fluid balance, blood pressure control, and hypercalcemia management, Chawla et al. recommend the furosemide stress test (FST) as a tool to predict AKI progression. Designing a test that predicts the probability of AKI progression will help us make better decisions regarding the optimal timing of RRT initiation. In this study, we aimed to evaluate the feasibility of using the FST test in determining the progression of AKI in patients hospitalized in the intensive care unit and the need for RRT using the noninvasive procedure furosemide stress test.
Read the detailed description
Acute kidney injury is defined by the KDIGO guidelines as an increase in serum creatinine ≥0.3 mg/dL (≥26.5 μmol/L) within the previous 48 hours, a ≥1.5-fold increase in serum creatinine from baseline that is known or presumed to have occurred within the previous seven days, or a urine volume of <0.5 mL/kg/h over six hours. In addition to the therapeutic role of furosemide in fluid balance, blood pressure control, and management of hypercalcemia, Chawla et al. recommend the furosemide stress test (FST) as a tool to predict AKI progression . Patients who develop AKI often require renal replacement therapy (RRT), but there is often no consensus on the optimal timing of initiation of RRT. RRT is an invasive procedure. The goal in AKI patients is to restore kidney function to normal without invasive intervention. However, a more conservative approach to starting RRT during the course of AKI may expose the patient to adverse outcomes. Therefore, designing a test that predicts the possibility of more severe AKI progression will help us make better decisions about the optimal timing of starting RRT. Albumin, sodium, potassium, chloride, magnesium, creatinine, glomerular filtration rate, urea and venous blood gases will be studied from the residual blood of the patients before FST. Creatinine, sodium, potassium, urea and microalbumin levels will be studied in the spot urine of the patients from the residual urine before FST. Fractional sodium-urea levels will be calculated with these results. The total urine volume will be calculated by collecting the 1st and 2st hour urines separately after FST and also the Na concentration will be measured from these urine samples. Systolic, diastolic and mean blood pressure levels obtained from the right arm with a noninvasive method (with a cuff) at the time of FST will be noted. In addition, persistent AKI risk index (PERSANT AKI risk index (PARI)), eGFR and kinetic GFR will be calculated and noted simultaneously with FST. Demographic data of the patients will be obtained from the hospital system. The lowest creatinine level in the last 6 months before application of the patients accepted to the study will be accepted as the basal creatinine level. If the creatinine level taken in the last 6 months cannot be reached, the lowest creatinine level reached before application will be accepted as the basal creatinine level.
Among the patients included in the study, 1 mg/kg furosemide will be administered to patients who have not used furosemide in the last 7 days within the first 24 hours following ICU admission, and 1.5 mg/kg furosemide will be administered intravenously as a push in patients exposed to furosemide. Patients who can pass 200 ml or more urine within the first 2 hours after furosemide application will be evaluated as positive for furosemide stress test.
Progression from AKI stage 1-2 to AKI stage 3 within 14 days after FST, need for RRT, total intensive care unit stay, development of persistent acute kidney injury (PAKi), number of RRT-independent days, renal recovery time and all-cause mortality will be evaluated
- Conditions
- Akut Kidney Injury
- Being tested
- Furosemide
- Keywords
- akut kidney injury, furosemide stres test, continuous renal replasman terapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Furosemide will be administered intravenously in the form of a push at a dose of 1 mg/kg to furosemide-naïve patients who meet the inclusion criteria and at a dose of 1.5 mg/kg to patients exposed to furosemide.
| Study group | Role | What they receive |
|---|---|---|
| Furosemide stress test application in AKI stage 1-2 according to kdigo criteria | Other | Among the patients included in the study, furosemide will be administered intravenously as a push at a dose of 1 mg/kg to patients who have not used furosemide in the last 7 days within the first 24 hours following ICU admission, and at a dose of 1.5 mg/kg to patients who have been exposed to furosemide. Patients who can pass 200 ml or more of urine within the first 2 hours after furosemide administration will be evaluated as having a positive furosemide stress test. Receives: Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression from AKI Stage 1-2 to Stage 3 within 14 days in patients who underwent furosemide stress test
Among the patients included in the study, within the first 24 hours following ICU admission, patients who have not used Furosemide within the last 7 days will be administered 1 mg/kg intravenously as a push for patients who have been exposed to furosemide, and 1.5 mg/kg for patients who have been exposed to furosemide. Patients who can excrete 200 ml or more urine within the first 2 hours after furosemide administration will be evaluated as having a positive furosemide stress test(FST). Our primary outcome is to determine how helpful it is in predicting progression from AKI stage 1-2 to AKI stage 3 within 14 days after the FST.
Measured: 14 days after FST
Secondary outcomes (4)
Renal Replacement Therapy
Incidence of patients requiring initiation of CRRT based on clinical indications
Measured: Within 14 days post-FST
Persistent AKI
Proportion of patients whose AKI persists beyond 48 hours from the Furosemide Stress Test, as defined by KDIGO criteria.
Measured: Up to 14 days post-FST
Hospital Stay
Total number of days spent in the hospital following the Furosemide Stress Test.
Measured: From date of FST until discharge or death (up to 90 days)
Mortality
All-cause mortality rate recorded within 28 days after the FST.
Measured: 28 days post-FST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Nov 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Akut 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mete Erdemir, Gulhane Training and Research Hospital
- Investigators
- gürhan t taşkın, Associate Professor, Study director, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765031
- Sponsor's protocol ID
- AEŞH-BADEK-2024-1037
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.
PubMed 24053972Gibney N, Hoste E, Burdmann EA, Bunchman T, Kher V, Viswanathan R, Mehta RL, Ronco C. Timing of initiation and discontinuation of renal replacement therapy in AKI: unanswered key questions. Clin J Am Soc Nephrol. 2008 May;3(3):876-80. doi: 10.2215/CJN.04871107. Epub 2008 Mar 5.
PubMed 18322044
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Furosemide Stress Test in Predicting Acute Kidney Injury Progression and Need for Renal Replacement Therapy in Patients Followed in the Intensive Care Clinic
- ClinicalTrials.gov ID
- NCT06765031
- Acronym / sponsor ID
- AEŞH-BADEK-2024-1037
- Conditions
- Akut Kidney Injury
- Keywords
- akut kidney injury, furosemide stres test, continuous renal replasman terapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 9 Jan 2025 (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.
AKI causes high mortality and morbidity, especially in critically ill patients, and prolongs the patient's stay in the intensive care unit. Due to the high morbidity and mortality associated with AKI, many researchers are studying several new biomarkers for earlier detection of AKI, determination of etiologies, and prediction of outcomes. However, the use of these new biomarkers may be limited due to reimbursement issues. In addition to the therapeutic role of furosemide in fluid balance, blood pressure control, and hypercalcemia management, Chawla et al. recommend the furosemide stress test (FST) as a tool to predict AKI progression. Designing a test that predicts the probability of AKI progression will help us make better decisions regarding the optimal timing of RRT initiation. In this study, we aimed to evaluate the feasibility of using the FST test in determining the progression of AKI in patients hospitalized in the intensive care unit and the need for RRT using the noninvasive procedure furosemide stress test.
Detailed description
Acute kidney injury is defined by the KDIGO guidelines as an increase in serum creatinine ≥0.3 mg/dL (≥26.5 μmol/L) within the previous 48 hours, a ≥1.5-fold increase in serum creatinine from baseline that is known or presumed to have occurred within the previous seven days, or a urine volume of <0.5 mL/kg/h over six hours. In addition to the therapeutic role of furosemide in fluid balance, blood pressure control, and management of hypercalcemia, Chawla et al. recommend the furosemide stress test (FST) as a tool to predict AKI progression . Patients who develop AKI often require renal replacement therapy (RRT), but there is often no consensus on the optimal timing of initiation of RRT. RRT is an invasive procedure. The goal in AKI patients is to restore kidney function to normal without invasive intervention. However, a more conservative approach to starting RRT during the course of AKI may expose the patient to adverse outcomes. Therefore, designing a test that predicts the possibility of more severe AKI progression will help us make better decisions about the optimal timing of starting RRT. Albumin, sodium, potassium, chloride, magnesium, creatinine, glomerular filtration rate, urea and venous blood gases will be studied from the residual blood of the patients before FST. Creatinine, sodium, potassium, urea and microalbumin levels will be studied in the spot urine of the patients from the residual urine before FST. Fractional sodium-urea levels will be calculated with these results. The total urine volume will be calculated by collecting the 1st and 2st hour urines separately after FST and also the Na concentration will be measured from these urine samples. Systolic, diastolic and mean blood pressure levels obtained from the right arm with a noninvasive method (with a cuff) at the time of FST will be noted. In addition, persistent AKI risk index (PERSANT AKI risk index (PARI)), eGFR and kinetic GFR will be calculated and noted simultaneously with FST. Demographic data of the patients will be obtained from the hospital system. The lowest creatinine level in the last 6 months before application of the patients accepted to the study will be accepted as the basal creatinine level. If the creatinine level taken in the last 6 months cannot be reached, the lowest creatinine level reached before application will be accepted as the basal creatinine level.
Among the patients included in the study, 1 mg/kg furosemide will be administered to patients who have not used furosemide in the last 7 days within the first 24 hours following ICU admission, and 1.5 mg/kg furosemide will be administered intravenously as a push in patients exposed to furosemide. Patients who can pass 200 ml or more urine within the first 2 hours after furosemide application will be evaluated as positive for furosemide stress test.
Progression from AKI stage 1-2 to AKI stage 3 within 14 days after FST, need for RRT, total intensive care unit stay, development of persistent acute kidney injury (PAKi), number of RRT-independent days, renal recovery time and all-cause mortality will be evaluated
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Furosemide stress test application in AKI stage 1-2 according to kdigo criteria | Other | Drug: FurosemideAmong the patients included in the study, furosemide will be administered intravenously as a push at a dose of 1 mg/kg to patients who have not used furosemide in the last 7 days within the first 24 hours following ICU admission, and at a dose of 1.5 mg/kg to patients who have been exposed to furosemide. Patients who can pass 200 ml or more of urine within the first 2 hours after furosemide administration will be evaluated as having a positive furosemide stress test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those who meet KDIGO AKI stage 1 and stage 2 criteria in the first 24 hours
- Those with sufficient fluid volume (CVP≥6 cmH20)
- Female and male patients over the age of 18 will be included in the study
Key exclusion criteria (13 listed)
- Pregnant patients
- Hospitalization due to intoxication
- Liver or kidney transplant
- Glomerular filtration rate below 30 ml/min/1.73m2
- Active bleeding
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 |
|---|---|---|
| FurosemideFurosemide will be administered intravenously in the form of a push at a dose of 1 mg/kg to furosemide-naïve patients who meet the inclusion criteria and at a dose of 1.5 mg/kg to patients exposed to furosemide. | Drug | Furosemide stress test application in AKI stage 1-2 according to kdigo criteria |
Primary outcome
Progression from AKI Stage 1-2 to Stage 3 within 14 days in patients who underwent furosemide stress test
Time frame: 14 days after FST
Among the patients included in the study, within the first 24 hours following ICU admission, patients who have not used Furosemide within the last 7 days will be administered 1 mg/kg intravenously as a push for patients who have been exposed to furosemide, and 1.5 mg/kg for patients who have been exposed to furosemide. Patients who can excrete 200 ml or more urine within the first 2 hours after furosemide administration will be evaluated as having a positive furosemide stress test(FST). Our primary outcome is to determine how helpful it is in predicting progression from AKI stage 1-2 to AKI stage 3 within 14 days after the FST.
4 secondary outcomes
Renal Replacement Therapy
Time frame: Within 14 days post-FST
Persistent AKI
Time frame: Up to 14 days post-FST
Hospital Stay
Time frame: From date of FST until discharge or death (up to 90 days)
Mortality
Time frame: 28 days post-FST
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 5 Aug 2026.
- Results publication: PubMed 24053972Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.
- Results publication: PubMed 18322044Gibney N, Hoste E, Burdmann EA, Bunchman T, Kher V, Viswanathan R, Mehta RL, Ronco C. Timing of initiation and discontinuation of renal replacement therapy in AKI: unanswered key questions. Clin J Am Soc Nephrol. 2008 May;3(3):876-80. doi: 10.2215/CJN.04871107. Epub 2008 Mar 5.
- Individual participant dataSharing planned: Yes
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.
gürhan t taşkın, Associate Professor study director
Gulhane Training and Research Hospital
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 in people with Akut Kidney Injury, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 13 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 5 Aug 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 Turkey (Türkiye). 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 from AKI Stage 1-2 to Stage 3 within 14 days in patients who underwent furosemide stress test (time frame: 14 days after FST). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06765031, which also lists 2 linked publications.
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 5 Aug 2026.