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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Места учебы
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45229
- Рекрутинг
- Cincinnati Children's Hospital Medical Center
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Контакт:
- Natalja L Stanski, MD, MS
- Номер телефона: 513-636-4334
- Электронная почта: natalja.stanski@cchmc.org
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Главный следователь:
- Natalja L Stanski, MD, MS
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Младший исследователь:
- Imogen Clover-Brown, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Day 7 Fluid Accumulation
Временное ограничение: 2 years
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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.
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2 years
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Implementation Acceptability, Feasibility, and Fidelity
Временное ограничение: 2 years
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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.
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2 years
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Change in ICU Free Days
Временное ограничение: 2 years
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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.
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2 years
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Change in Continuous Renal Replacement Therapy Use
Временное ограничение: 2 years
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Rate of CRRT use, timing of initiation, and duration between eligible patients in the 2 years post-implementation to the 2 years pre-implementation.
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2 years
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Change in Vasoactive Inotropic Score after FST
Временное ограничение: 2 hours
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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.
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2 hours
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Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB No. 2025-0678
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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