跳至主要内容
临床试验/NCT03541785
NCT03541785Enrolling By Invitation不适用

Use of NGAL to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children With Acute Kidney Injury

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
420
试验地点
1
主要终点
Clinical Decision Support Success (CDS)

研究概览

简要总结

This study follows a group of patients admitted to the PICU who are identified as being at risk for developing acute kidney injury. The investigators will use risk-stratification, biomarker testing, and a functional assessment to predict patients who will become fluid overloaded and develop acute kidney injury.

详细描述

In the pediatric population, acute kidney injury (AKI) is commonly observed in critically ill patients. At this time, there are no standardized care pathways that begin at identifying patients at risk for developing AKI and progress through to early recognition and treatment. Through previous work, the investigators have developed, tested, and integrated an AKI risk-stratification/clinical recognition tool (RAI) and a urine biomarker (NGAL) to try to identify patients at risk vs. not at-risk for developing AKI. However, these factors alone have yet to be integrated into clinical decision support to optimize AKI therapies and patient outcomes. The furosemide stress test (FST), previously described in adults, may be a good predictor for the patients who need acute dialysis for AKI versus those that can be managed medically.

Through this study, the investigators will be following a cohort of patients admitted to the PICU who are identified as being at risk for developing AKI through RAI and NGAL results. The aim is to standardize the FST in this population, as well as determine the accuracy of the RAI-NGAL-FST clinical decision tool in predicting patients who become fluid overloaded and develop AKI.

研究设计

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

入排标准

年龄范围
3 Months 至 25 Years(Child, Adult)
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
  • Urine NGAL greater than or equal to 150 ng/mL
  • Indwelling urinary catheter

排除标准

  • Evidence of volume depletion
  • Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR <60 mL/min/1.73m2)
  • History of kidney transplantation
  • Active DNR order or clinical team is not committed to escalating medical care
  • Known history of allergic reaction to furosemide (only for FST)

结局指标

主要结局

Clinical Decision Support Success (CDS)

时间窗: 48 hours of PICU admission

Time to complete risk stratification (RAI), biomarker testing (NGAL), and functional kidney assessment (FST) is less than 48 hours

次要结局

  • Furosemide Stress Test (FST) Standardization(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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