AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 900
- 试验地点
- 6
- 主要终点
- Rate of AKI in hospitalized VAD patients based on AKIN criteria
研究概览
简要总结
The investigators are doing this research to investigate whether multifaceted preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications
详细描述
The purpose of the study is to investigate whether preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications
Participants will be in the study for the first 7 days of hospitalization. The study investigators will access the electronic medical record daily from admission day 1 through admission day 7 in order to provide clinical recommendations in an effort to minimize AKI risk as per routine practice.
If the patient is discharged prior to day 7 the study, intervention will be terminated on day of discharge.
The investigators will review the participant's medical record up to one year after surgery.
This study will not include any experimental laboratory tests or experimental medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Subjects with VAD in place
Adult patients with VAD in place who are admitted to the hospital for acute medical illness. The investigators will provide clinical recommendations to the subject's primary care provider.
干预措施: Clinical Recommendations (Other)
结局指标
主要结局
Rate of AKI in hospitalized VAD patients based on AKIN criteria
时间窗: The first 7 days of hospitalization
The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output \<0.5 ml/kg/h for 6 h; 2) serum creatinine increase \> 2.0-3.0 fold from baseline OR urine output \<0.5 ml/kg/h for 12 h; 3) serum creatinine increase \>3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output \<0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT
Severity of AKI based on AKIN stages (I, II, III) 1
时间窗: The first 7 days of the hospitalization
The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output \<0.5 ml/kg/h for 6 h; 2) serum creatinine increase \> 2.0-3.0 fold from baseline OR urine output \<0.5 ml/kg/h for 12 h; 3) serum creatinine increase \>3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output \<0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT
次要结局
- In hospital, 60 day and one-year mortality(One year after enrollment)
- Length of hospital stay(One year after hospitalization)
研究者
Qi Qian, M.D.
Principal Investigator
Mayo Clinic