An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury: A Randomized Trial of an Early Standardized, Personalized Nephrology Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Peak change in milligrams per deciliter (mg/dL) in serum creatinine (SCr) level over a 7-day interval
研究概览
简要总结
This is a single center randomized trial that seeks to determine if the use of an automated real-time electronic medical record Acute Kidney Injury (AKI) risk score can improve patient outcomes through the use of an early standardized nephrology focused intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Age >18 years old
- •Initial ESTOP AKI score ≥0.01 within the last 8 hours.
排除标准
- •Voluntary refusal or missing written consent of the patient / legal representative.
- •Patients with a known history of end-stage renal disease on dialysis (including renal transplantation).
- •Patients without a measured serum creatinine value during their inpatient stay.
- •Patients with a creatinine >4.0 mg/dl at the time of admission or available in the electronic health record (EHR) from the last 6 months.
- •Patients with prior episode of Kidney Disease Improving Global Outcomes (KDIGO) defined AKI during this same hospitalization- regardless of ESTOP AKI score.
- •Patients with prior renal consultation during their admission.
研究组 & 干预措施
Early Nephrology Consult (ENC)
The ENC will be a structured consultative note that will provide detailed recommendations around issues such as Differential Diagnosis, Drug Dosing and Volume Status. The research ENC will have a daily follow-up with documented recommendations.
干预措施: Early Nephrology Consult (ENC) (Other)
Standard of Care (SOC)
Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
Peak change in milligrams per deciliter (mg/dL) in serum creatinine (SCr) level over a 7-day interval
时间窗: 7-day interval
The primary endpoint of interest, change in serum creatinine (SCr), is the peak change from study entry in SCr level over a 7-day interval. The change in SCr is defined as the maximal change in creatinine over this interval, and aim to detect a clinical difference in change in SCr between the SOC and ENC treatment groups.
次要结局
未报告次要终点