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临床试验/NCT02660931
NCT02660931已完成不适用

Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 12,108 人开始时间: 2016年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12,108
试验地点
2
主要终点
Number of Serum Creatinine Tests Ordered

研究概览

简要总结

This proposal will incorporate statistical models developed by the investigators to predict risk for acute kidney injury into our electronic medical record system, enabling an alert to notify providers of the risk status. Pediatric inpatients will be randomly assigned to be in the intervention group, for whom the notification will be implemented, or in the control group, who will receive usual care (no notification). The investigators believe the notification will increase appropriate screening for acute kidney injury and reduce the severity of acute kidney injury in the intervention group.

详细描述

This proposal will incorporate a logistic regression models developed by the investigators to predict risk for acute kidney injury in pediatric intensive care unit and pediatric ward patients into the electronic medical record system, enabling personalized decision support. Real-time surveillance using the risk prediction models will identify pediatric inpatients at increased risk for acute kidney injury. When patients exceed the threshold risk for acute kidney injury, the electronic medical record system will notify providers. Patients will be randomly assigned to be in the intervention group, for whom the notification will be implemented, or in the control group, for whom the notification will not display. The risk notification will be assessed for its impact on outcomes including rates of screening for acute kidney injury and the severity of acute kidney injury.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
28 Days 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All admissions to the pediatric intensive care unit or pediatric wards at the Monroe Carell Junior Children's Hospital at Vanderbilt

排除标准

  • Prior diagnosis of chronic renal disease, including dialysis and transplant
  • Admission to the Neonatal Intensive Care Unit during the current admission

研究组 & 干预措施

AKI Risk Notification

Experimental

Patients randomized to this arm will be eligible for an acute kidney injury risk notification, if their calculated risk exceeds the threshold during their inpatient encounter.

干预措施: AKI Risk Notification (Other)

Usual Care

No Intervention

These patients will receive usual clinical care, with no acute kidney injury risk notification.

结局指标

主要结局

Number of Serum Creatinine Tests Ordered

时间窗: Admission through Discharge (approximately 2 days to 1 week)

Measure of efficacy of the clinical decision support to lead to increased screening for acute kidney injury.

次要结局

  • Renal Replacement Therapy (number requiring RRT)(Admission through Discharge (approximately 2 days to 1 week))
  • Length of Stay (days)(Admission through Discharge (approximately 2 days to 1 week))
  • Acute Kidney Injury Severity (as measured by Kidney Disease Improving Global Outcomes [KDIGO] stage 1, 2 or 3)(Admission through Discharge (approximately 2 days to 1 week))
  • In-hospital Mortality(Admission through Discharge (approximately 2 days to 1 week))

研究者

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

Sara Van Driest

Assistant Professor

Vanderbilt University Medical Center

研究点 (2)

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