Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score (PRAIOC-RISKS)
Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score - a Pilot Feasibility Randomized Controlled Trial
研究概览
详细说明
Background and rationale AKI is common in the intensive care unit .It contributes significantly to mortality and morbidity .the estimated incidence or AKI among critically ill patients is 30-40% and morality is high.
There is a well recognized gap between the optimal care and the delivered care regarding prevention and management of AKI.
The focus over the last few years has been on early detection. A panel of urinary biomarkers have proved helpful for early detection of AKI. However the cost and low specificity make no single one of them solely reliable .using a panel of bio-markers increases their specificity.
The concept of electronic alerts has been recently introduced. Some trials have been testing its impact on the outcome of AKI. The benefit of electronic alerts is still uncertain .A meta-analysis is currently underway to synthesize stronger evidence of electronic alerts benefit.
Another evolving area, is the development of risk score to predict AKI and and hence applying timely preventive measures.
KDIGO recommends applying preventive measures to high risk patients. However no study to date has tested risk scores based interventions
Hypothesis:
We will use the recently validated score to predict AKI in ICU patients. We will then apply preventive measures. To patients at risk .To our knowledge this is the first study to apply preventive interventions based on AKI risk score assessment
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Cairo、埃及
- Cairo University Hospitals
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
All adult patients (≥18 year old) admitted to the intensive care unit and do not fulfill the criteria for the diagnosis of AKI by Kidney Disease Improving Global Outcome (KDIGO) definition
Exclusion Criteria:
- Patients who have already developed AKI at the time of intensive care unit ICU admission.
- Patients with insufficient medical records to obtain previous medical history
- Patients who lack mental capacity
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Observational
patients will be recruited to this arm to observe prospectively the incidence of AKI among critically ill patients.patients
will receive the standard care.No other intervention will be delivered
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有源比较器：Interventional
Patients in this arm will be subject to AKI risk score.
This risk score was recently developed and validated in Mayo clinic the intervention will be Measures to prevent AKI among critically ill patients
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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 |
|---|---|---|
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Incidence of AKI
大体时间：during 7 days of ICU admission
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We will compare the incidence rate between the interventional and the observational arm
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during 7 days of ICU admission
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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30 day mortality
大体时间：30 days
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all cause mortality during 30 days of ICU admission or within 30 days of developement of AKI
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30 days
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Time to recovery after development of AKI
大体时间：30 days
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Time interval between the diagnosis of AKI and recovery of either blood chemistry or oliguria
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30 days
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Deterioration of AKI stage
大体时间：30 days
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Transition from initial stage KDIGO stage 1 to either 2 or 3 .Transition from initial stage 2 to 3
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30 days
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Duration of dialysis dependency
大体时间：30 days
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time patient remains dialysis-dependant after severe AKI.
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30 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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