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

2026年7月17日 更新者:Natalja Stanski、Children's Hospital Medical Center, Cincinnati

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

120

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Cincinnati、Ohio、美国、45229
        • 招聘中
        • Cincinnati Children's Hospital Medical Center
        • 接触:
        • 首席研究员:
          • Natalja L Stanski, MD, MS
        • 副研究员:
          • Imogen Clover-Brown, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Critically ill patients admitted to the PICU at Cincinnati Children's Hospital Medical Center identified as being high risk for developing AKI (RAI+/NGAL+)

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Day 7 Fluid Accumulation
大体时间: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.
2 years

次要结果测量

结果测量
措施说明
大体时间
Implementation Acceptability, Feasibility, and Fidelity
大体时间:2 years
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
大体时间:2 years
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
大体时间:2 years
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
大体时间:2 hours
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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月27日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年7月10日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月17日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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