NCT06765031

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

December 19, 2024

Last Update Submit

January 8, 2026

Conditions

Keywords

akut kidney injuryfurosemide stres testcontinuous renal replasman terapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    14 days after FST

Secondary Outcomes (4)

  • Renal Replacement Therapy

    Within 14 days post-FST

  • Persistent AKI

    Up to 14 days post-FST

  • Hospital Stay

    From date of FST until discharge or death (up to 90 days)

  • Mortality

    28 days post-FST

Study Arms (1)

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.

Drug: Furosemide

Interventions

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.

Furosemide stress test application in AKI stage 1-2 according to kdigo criteria

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, keçiören, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

MeSH Terms

Interventions

Furosemide

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • gürhan t taşkın, Associate Professor

    Gulhane Training and Research Hospital

    STUDY DIRECTOR

Central Study Contacts

mete e erdemir, intensive care specialist

CONTACT

gürhan T taşkın, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 9, 2025

Study Start

November 1, 2024

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

January 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations