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临床试验/NCT04376619
NCT04376619撤回不适用

Alert Kidney Intervention

Atlantic Health System0 个研究点开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
number of participants who required dialysis

研究概览

简要总结

Acute kidney injury increases the risk for chronic kidney disease, length of stay, readmissions and mortality. Currently the only way to diagnose acute kidney injury is with a serum creatinine or drop in urine output. Biomarkers for acute kidney injury are well elevated before rise in creatinine. Hypothesis is that by implementing an electronic alert system with an algorithm followed by remote ischemic preconditioning will prevent acute kidney injury.

详细描述

The propose study is to incorporate an alert system in current medical health system and an algorithm will be used to activate clinicians and Nephrologist to confirm if patient is at high risk. Once identified as high risk the clinician and/or nephrologist will intervene and change current management if needed. First phase of study will look at an alert system and algorithm was enough to lower incidence of acute kidney injury. Phase 2 will also use alert system and algorithm that will be further randomized those that are identified as high risk for acute kidney injury to remote ischemic preconditioning.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • any admitted patients that are not excluded by exclusion criteria
  • Patients who's creatinine returns to baseline after admitted can be included in study if patient still remains admitted.

排除标准

  • End stage renal disease
  • estimated glomerular filtration rate less then 20
  • Left ventricular assist device patients
  • observation status
  • hospice patients
  • pregnancy
  • age less then 18
  • acute kidney injury on admission defined as 1.5 times elevated creatinine prior to last admission's creatinine
  • nephrology consult already placed
  • renal transplant or nephrectomy within 1 year
  • Patients unable to provide consent
  • exclusion for remote ischemic preconditioning in addition to above exclusion will be:
  • symptoms or diagnosis of peripheral arterial disease
  • Patients in shock defined by requiring inotropes or vasopressors

结局指标

主要结局

number of participants who required dialysis

时间窗: during hospitalization, up to three months

need for initiation of dialysis after acute kidney injury develops during the admission

number of participants who developed acute kidney injury

时间窗: during hospitalization, up to three months

development of acute kidney injury as measured by serum creatinine 1.5 times more then baseline

次要结局

  • number of participants who are placed on hospice or have expired(at time of admission when enrolled in study to 1 year post discharge)
  • number of participants who are readmitted(discharged from when enrolled in study to 1 year post discharge)
  • length of stay(during hospitalization, up to three months)
  • progression to chronic kidney disease(at time of admission when enrolled in study to 1 year post discharge)
  • number of participants who receive dialysis(at time of admission when enrolled in study to 1 year post discharge)

研究者

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

Shivangi K. Patel

Principal Investigator

Atlantic Health System

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