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Recruiting NCT07718464

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

Observational Acute Kidney Injury Renal Replacement Therapy Pediatric Intensive Care Unit

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Furosemide Stress Test Clinical Decision Support Tool.
Who it may be relevant to
Registry conditions: Acute Kidney Injury, Renal Replacement Therapy, Pediatric Intensive Care Unit. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Furosemide Stress Test Implementation and Outcomes in Critically Ill Children at High Risk for Acute Kidney Injury: A Hybrid Study

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in Day 7 Fluid Accumulation [Time frame: 2 years]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Cincinnati Children's Hospital Medical Center — Cincinnati

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. eCollecti PMID 35967111
  • 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

Identifiers

NCT: NCT07718464 · IRB No. 2025-0678

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗