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临床试验/NCT07718464
NCT07718464招募中不适用

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

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Change in Day 7 Fluid Accumulation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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+)

排除标准

  • Receipt of renal replacement therapy prior to PICU admission

结局指标

主要结局

Change in Day 7 Fluid Accumulation

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natalja Stanski

Co-Director, Center for Acute Care Nephrology; Attending Physician, Pediatric Intensive Care Unit (PICU); Associate Professor, UC Department of Pediatrics

Children's Hospital Medical Center, Cincinnati

研究点 (1)

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