FST Analysis Supporting Timely Therapy and Risk Assessment Via Clinical Decision Support for Kids

NCT07718464 | Recruiting

• 1 other identifier: IRB No. 2025-0678
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Acute Kidney Injury; Renal Replacement Therapy; Pediatric Intensive Care Unit

Keywords

NGAL; Renal Angina Index; Furosemide Stress Test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Implementation Acceptability, Feasibility, and Fidelity

  2 years

• Change in ICU Free Days

  2 years

• Change in Continuous Renal Replacement Therapy Use

  2 years

• Change in Vasoactive Inotropic Score after FST

  2 hours

Study Arms (1)

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

Interventions

Furosemide Stress Test Clinical Decision Support Tool OTHER

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.

Post-Implementation Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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+)

You may qualify if:

• 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+)

You may not qualify if:

• Receipt of renal replacement therapy prior to PICU admission

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 35967111 BACKGROUND

• 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.

  PMID: 41426025 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will collect daily opportunistic urine specimens up to 7 days from discarded urine for patients with an indwelling bladder catheter and from laboratory residuals. This urine will be frozen and later batch processed to study urinary biomarkers.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Center for Acute Care Nephrology; Attending Physician, Pediatric Intensive Care Unit (PICU); Associate Professor, UC Department of Pediatrics

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 22, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

US (1)