Optimizing Electronic Alerts for Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,030
- 试验地点
- 2
- 主要终点
- Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death
研究概览
简要总结
This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them to usual care versus an electronic alert coupled to a "best practices" order set.
详细描述
Acute kidney injury (AKI) carries a significant, independent risk of mortality among hospitalized patients. Recent studies have demonstrated increased mortality among patients with even small increases in serum creatinine concentration. International guidelines for the treatment of AKI focus on appropriate management of drug dosing, avoiding nephrotoxic exposures, and careful attention to fluid and electrolyte balance. Early nephrologist involvement may also improve outcomes in AKI. Without appropriate provider recognition of AKI, however, none of these measures can be taken, and patient outcomes may suffer. AKI is frequently overlooked by clinicians, but carries a substantial cost, morbidity and mortality burden.
The investigators conducted a pilot, randomized trial of electronic alerts for acute kidney injury in 2014. The trial, which randomized 2400 patients with AKI as defined by an increase in creatinine of 0.3mg/dl over 48 hours or 50% over 7 days, found that alerting physicians to the presence of AKI did not improve the course of acute kidney injury, reduce dialysis or death rates. However this study was conducted in a single hospital, and the alert itself did not describe specific actions that a provider could take. In the present proposal, the investigators seek to expand upon their prior study to determine both the modes of alerting that would be most effective and to determine if targeting alerts (such as to patients on medications that may worsen acute kidney injury) will improve effectiveness.
This study will be a randomized, controlled trial of an electronic AKI alert system. Using the Kidney Disease: Improve Global Outcomes creatinine criteria, inpatients at several hospitals will be randomized to usual care versus electronic alerting. The primary outcome will be a composite of progression of acute kidney injury, dialysis and death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adult ≥ 18 years admitted to a participating study hospital
- •Acute Kidney Injury as defined by KDIGO consensus creatinine criteria (0.3mg/dl increase in serum creatinine over 48 hours or 50% relative increase over 7 days).
排除标准
- •ESKD diagnosis code
- •Dialysis order prior to AKI onset
- •Initial creatinine >=4.0mg/dl
- •Prior admission in which patient was randomized.
- •Admission to hospice service or comfort measures only order
- •Kidney transplant within 6 months
结局指标
主要结局
Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death
时间窗: 14 days from randomization
Progression of AKI is defined by an increase in KDIGO creatinine stage from that present at the time of randomization. Dialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments (for the purpose of volume removal) will not be included. Mortality will be determined from hospital administrative records.
次要结局
- Dialysis(14 days from randomization)
- AKI Progression(14 days from randomization)
- Mortality(14 days from randomization)
- Index Hospitalization Cost(Index hospitalization through discharge, up to one year)
- AKI Duration(14 days from randomization)
- Readmission Rate(30 days from randomization)
- Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization(24 hours from randomization to discharge, up to one year)
- Number of Subjects With Chart Documentation of AKI(Index hospitalization)