Acute Kidney InjuryFAST TRACKNCT07718464
FST Analysis Supporting Timely Therapy and Risk Assessment Via Clinical Decision Support for Kids
An observational study of Acute Kidney Injury and Renal Replacement Therapy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The goal of this study is to learn whether adding a clinical decision support tool to the electronic medical record helps clinicians use the furosemide stress test in critically ill children at high risk for severe acute kidney injury (AKI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury, Renal Replacement Therapy, Pediatric Intensive Care Unit
- What is being tested?
- Furosemide Stress Test Clinical Decision Support Tool
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill patients admitted to the PICU at Cincinnati Children's Hospital Medical Center identified as being high risk for developing AKI (RAI+/NGAL+)
Who may be able to join
- Admitted to the pediatric intensive care unit (PICU)
- Renal Angina Index (RAI) greater than or equal to 8 (RAI+)
- Urine NGAL greater than or equal to 150 ng/mL (NGAL+)
Who cannot join
- Receipt of renal replacement therapy prior to PICU admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Natalja L Stanski, MD, MS, 513-636-4334, natalja.stanski@cchmc.org
Natalja L Stanski, MD, MS
About this study
Official title: Furosemide Stress Test Implementation and Outcomes in Critically Ill Children at High Risk for Acute Kidney Injury: A Hybrid Study
The goal of this study is to learn whether adding a clinical decision support tool to the electronic medical record helps clinicians use the furosemide stress test in critically ill children at high risk for severe acute kidney injury (AKI). The main question it aims to answer is: Does implementing the decision support tool reduce fluid overload and help predict which children will receive dialysis?
Researchers will identify children admitted to the pediatric intensive care unit who are at high risk for AKI using risk stratification and biomarker testing, then compare outcomes in the two years after the tool is introduced with the two years before.
Read the detailed description
Acute kidney injury (AKI) is common in critically ill children, and continuous renal replacement therapy (CRRT) is a mainstay of treatment for severe AKI. Delayed initiation of CRRT is associated with worse outcomes, but because CRRT carries risks, tools are needed to identify which patients will truly benefit from early initiation. Through previous work, the investigators have developed, tested, and integrated an AKI risk-stratification tool (the Renal Angina Index, RAI) and a urine biomarker (neutrophil gelatinase-associated lipocalin, NGAL) to identify patients at risk for developing severe AKI. The furosemide stress test (FST), previously validated in adults, measures urine output after a standardized dose of furosemide and may help predict which patients will receive dialysis versus those who can be managed medically. However, despite existing clinical decision support, fewer than half of eligible patients currently undergo an FST, suggesting that implementation varies by clinician preference rather than patient factors.
The investigators will follow a cohort of patients admitted to the PICU who are identified as being at high risk for developing severe AKI through RAI and NGAL screening. Using a hybrid type 1 effectiveness-implementation design, the aim is to develop and implement a clinical decision support intervention that standardizes FST use in this population, evaluate whether this intervention is acceptable and feasible to clinicians, and determine its impact on patient outcomes. Outcomes in the two years after implementation will be compared with the two years before, with the primary outcome of reducing fluid overload. The investigators will also assess whether urine flow rate after the FST predicts receipt of CRRT and confirm that performing the FST does not increase the need for blood-pressure support.
- Being tested
- Furosemide Stress Test Clinical Decision Support Tool
- Keywords
- NGAL, Renal Angina Index, Furosemide Stress Test
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide Stress Test Clinical Decision Support ToolOther
The CDS strategy will be developed with key stakeholders in the Cincinnati Children's PICU, leveraging existing infrastructure and workflows. This CDS intervention will then be implemented as part of routine care in the PICU.
| Study group | Role | What they receive |
|---|---|---|
| Post-Implementation Cohort | All patients with RAI greater than or equal to 8 (RAI+) and NGAL greater than or equal to 150 ng/mL (NGAL+) in the two years after the clinical decision support tool is implemented. These patients will be compared to the cohort of patients with RAI greater than or equal to 8 and NGAL greater than or equal to 150 ng/mL in the two years before the clinical decision support (CDS) tool is implemented. Receives: Other: Furosemide Stress Test Clinical Decision Support Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Day 7 Fluid Accumulation
Median Day 7 percent fluid accumulation will be compared between eligible patients in the 2 years post-implementation and the 2 years pre-implementation. Percent fluid accumulation will be calculated as cumulative fluid balance (in liters) divided by baseline body weight (in kilograms) multiplied by 100 to obtain a percentage.
Measured: 2 years
Secondary outcomes (4)
Implementation Acceptability, Feasibility, and Fidelity
Acceptability to clinicians, feasibility to implement within PICU workflows, and fidelity of delivery of intervention will be assessed. Acceptability and feasibility will be measured with the Acceptability of Intervention Measure (AIM) and Feasibility of Intervention measure (FIM) tools. Results of each tool will be analyzed to determine the mean and standard deviation of each question and summary scores for the complete tool. Fidelity will be assessed by comparing the proportion of RAI+/NGAL+ patients who receive an FST in the post-implementation period compared to the pre-implementation period. Barriers and facilitators to fidelity of our intervention will be explores using semi-structured interviews (SSIs) and RedCap surveys of clinicians.
Measured: 2 years
Change in ICU Free Days
Median ICU free days will be compared between eligible patients in the 2 years post-implementation and the 2 years pre-implementation. ICU free days will be calculated as 28 days minus the total number of days in the ICU with patients who die before day 28 assigned 0.
Measured: 2 years
Change in Continuous Renal Replacement Therapy Use
Rate of CRRT use, timing of initiation, and duration between eligible patients in the 2 years post-implementation to the 2 years pre-implementation.
Measured: 2 years
Change in Vasoactive Inotropic Score after FST
For patients who undergo FST, change in Vasoactive Intropic Score (VIS) will be compared from immediately before FST to 2 hours after FST. This will serve as a balancing measure to evaluate safety of intervention.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start27 May 2026
- Primary completionMay 2028 (estimated)
- Study completionJun 2028 (estimated)
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 Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalja Stanski, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718464
- Sponsor's protocol ID
- IRB No. 2025-0678
- Acronym
- FAST TRACK
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our regulatory approval allows for sharing of de-identified data for future research, if applicable or warranted. Currently, we have no plans or agreements in place to share the data with other researchers.
Publications
Goldstein SL, Krallman KA, Kirby C, Roy JP, Collins M, Fox K, Schmerge A, Wilder S, Gerhardt B, Chima R, Basu RK, Chawla L, Fei L. Integration of the Renal Angina Index and Urine Neutrophil Gelatinase-Associated Lipocalin Improves Severe Acute Kidney Injury Prediction in Critically Ill Children and Young Adults. Kidney Int Rep. 2022 May 25;7(8):1842-1849. doi: 10.1016/j.ekir.2022.05.021. eCollection 2022 Aug.
PubMed 35967111Clover-Brown I, Ceschia G, Gist KM, Hasson DC, Krallman KA, Standage SW, Goldstein SL, Stanski NL. Furosemide Stress Test Use in Children at Risk for Acute Kidney Injury. Kidney Int Rep. 2025 Oct 1;10(12):4241-4251. doi: 10.1016/j.ekir.2025.09.029. eCollection 2025 Dec.
PubMed 41426025
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furosemide Stress Test Implementation and Outcomes in Critically Ill Children at High Risk for Acute Kidney Injury: A Hybrid Study
- ClinicalTrials.gov ID
- NCT07718464
- Acronym / sponsor ID
- FAST TRACK / IRB No. 2025-0678
- Keywords
- NGAL, Renal Angina Index, Furosemide Stress Test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 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 study is to learn whether adding a clinical decision support tool to the electronic medical record helps clinicians use the furosemide stress test in critically ill children at high risk for severe acute kidney injury (AKI). The main question it aims to answer is: Does implementing the decision support tool reduce fluid overload and help predict which children will receive dialysis?
Researchers will identify children admitted to the pediatric intensive care unit who are at high risk for AKI using risk stratification and biomarker testing, then compare outcomes in the two years after the tool is introduced with the two years before.
Detailed description
Acute kidney injury (AKI) is common in critically ill children, and continuous renal replacement therapy (CRRT) is a mainstay of treatment for severe AKI. Delayed initiation of CRRT is associated with worse outcomes, but because CRRT carries risks, tools are needed to identify which patients will truly benefit from early initiation. Through previous work, the investigators have developed, tested, and integrated an AKI risk-stratification tool (the Renal Angina Index, RAI) and a urine biomarker (neutrophil gelatinase-associated lipocalin, NGAL) to identify patients at risk for developing severe AKI. The furosemide stress test (FST), previously validated in adults, measures urine output after a standardized dose of furosemide and may help predict which patients will receive dialysis versus those who can be managed medically. However, despite existing clinical decision support, fewer than half of eligible patients currently undergo an FST, suggesting that implementation varies by clinician preference rather than patient factors.
The investigators will follow a cohort of patients admitted to the PICU who are identified as being at high risk for developing severe AKI through RAI and NGAL screening. Using a hybrid type 1 effectiveness-implementation design, the aim is to develop and implement a clinical decision support intervention that standardizes FST use in this population, evaluate whether this intervention is acceptable and feasible to clinicians, and determine its impact on patient outcomes. Outcomes in the two years after implementation will be compared with the two years before, with the primary outcome of reducing fluid overload. The investigators will also assess whether urine flow rate after the FST predicts receipt of CRRT and confirm that performing the FST does not increase the need for blood-pressure support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Implementation Cohort | – | Other: Furosemide Stress Test Clinical Decision Support ToolAll patients with RAI greater than or equal to 8 (RAI+) and NGAL greater than or equal to 150 ng/mL (NGAL+) in the two years after the clinical decision support tool is implemented. These patients will be compared to the cohort of patients with RAI greater than or equal to 8 and NGAL greater than or equal to 150 ng/mL in the two years before the clinical decision support (CDS) tool is implemented. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients admitted to the PICU at Cincinnati Children's Hospital Medical Center identified as being high risk for developing AKI (RAI+/NGAL+)
Key inclusion criteria (3 listed)
- Admitted to the pediatric intensive care unit (PICU)
- Renal Angina Index (RAI) greater than or equal to 8 (RAI+)
- Urine NGAL greater than or equal to 150 ng/mL (NGAL+)
Key exclusion criteria (1 listed)
- Receipt of renal replacement therapy prior to PICU admission
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 Test Clinical Decision Support ToolThe CDS strategy will be developed with key stakeholders in the Cincinnati Children's PICU, leveraging existing infrastructure and workflows. This CDS intervention will then be implemented as part of routine care in the PICU. | Other | Post-Implementation Cohort |
Primary outcome
Change in Day 7 Fluid Accumulation
Time frame: 2 years
Median Day 7 percent fluid accumulation will be compared between eligible patients in the 2 years post-implementation and the 2 years pre-implementation. Percent fluid accumulation will be calculated as cumulative fluid balance (in liters) divided by baseline body weight (in kilograms) multiplied by 100 to obtain a percentage.
4 secondary outcomes
Implementation Acceptability, Feasibility, and Fidelity
Time frame: 2 years
Change in ICU Free Days
Time frame: 2 years
Change in Continuous Renal Replacement Therapy Use
Time frame: 2 years
Change in Vasoactive Inotropic Score after FST
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 35967111Goldstein SL, Krallman KA, Kirby C, Roy JP, Collins M, Fox K, Schmerge A, Wilder S, Gerhardt B, Chima R, Basu RK, Chawla L, Fei L. Integration of the Renal Angina Index and Urine Neutrophil Gelatinase-Associated Lipocalin Improves Severe Acute Kidney Injury Prediction in Critically Ill Children and Young Adults. Kidney Int Rep. 2022 May 25;7(8):1842-1849. doi: 10.1016/j.ekir.2022.05.021. eCollection 2022 Aug.
- Background: PubMed 41426025Clover-Brown I, Ceschia G, Gist KM, Hasson DC, Krallman KA, Standage SW, Goldstein SL, Stanski NL. Furosemide Stress Test Use in Children at Risk for Acute Kidney Injury. Kidney Int Rep. 2025 Oct 1;10(12):4241-4251. doi: 10.1016/j.ekir.2025.09.029. eCollection 2025 Dec.
- Individual participant dataSharing planned: Undecided. Our regulatory approval allows for sharing of de-identified data for future research, if applicable or warranted. Currently, we have no plans or agreements in place to share the data with other researchers.
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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.
Cincinnati Children's Hospital Medical Center
Cincinnati, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Renal Replacement Therapy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 22 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Day 7 Fluid Accumulation (time frame: 2 years). 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 NCT07718464, 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 22 Jul 2026.