FST Analysis Supporting Timely Therapy and Risk Assessment Via Clinical Decision Support for Kids (FAST TRACK)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; Renal Replacement Therapy; Pediatric Intensive Care Unit
• Intervention / Treatment: Other: Furosemide Stress Test Clinical Decision Support Tool

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Natalja L Stanski, MD, MS; Phone Number: 513-636-4334; Email: natalja.stanski@cchmc.org
      • Principal Investigator: Natalja L Stanski, MD, MS
      • Sub-Investigator: Imogen Clover-Brown, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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+)

Description

Inclusion Criteria:

• 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+)

Exclusion Criteria:

• Receipt of renal replacement therapy prior to PICU admission

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Furosemide Stress Test Clinical Decision Support Tool; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	2 hours

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General 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.
• Clover-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.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: NGAL; Furosemide Stress Test; Renal Angina Index
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: IRB No. 2025-0678

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No