- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06765031
The Role of Furosemide Stress Test in the Intensive Care Clinic
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
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: mete e erdemir, intensive care specialist
- Phone Number: +905066321175
- Email: meteerdemir@hotmail.com
Study Contact Backup
- Name: gürhan t taşkın, Associate Professor
- Phone Number: +905057202781
- Email: drgurhantaskin@gmail.com
Study Locations
-
-
keçiören
-
Ankara, keçiören, Turkey (Türkiye), 06010
- Recruiting
- Gulhane Training and Research Hospital
-
Contact:
- mete e erdemir, intensive care specialist
- Phone Number: +905066321175
- Email: meteerdemir@hotmail.com
-
Contact:
- gürhan t taşkın, Associate Professor
- Phone Number: +905057202781
- Email: drgurhantaskin@gmail.com
-
Sub-Investigator:
- mete e erdemir, intensive care specialist
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Furosemide stress test application in AKI stage 1-2 according to kdigo criteria
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
14 days after FST
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Renal Replacement Therapy
Time Frame: Within 14 days post-FST
|
Incidence of patients requiring initiation of CRRT based on clinical indications
|
Within 14 days post-FST
|
|
Persistent AKI
Time Frame: Up to 14 days post-FST
|
Proportion of patients whose AKI persists beyond 48 hours from the Furosemide Stress Test, as defined by KDIGO criteria.
|
Up to 14 days post-FST
|
|
Hospital Stay
Time Frame: From date of FST until discharge or death (up to 90 days)
|
Total number of days spent in the hospital following the Furosemide Stress Test.
|
From date of FST until discharge or death (up to 90 days)
|
|
Mortality
Time Frame: 28 days post-FST
|
All-cause mortality rate recorded within 28 days after the FST.
|
28 days post-FST
|
Collaborators and Investigators
Investigators
- Study Director: gürhan t taşkın, Associate Professor, Gulhane Training and Research Hospital
Publications and helpful links
General 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.
- Gibney 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-BADEK-2024-1037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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