AKI Prevention and Early Intervention in Patients Undergoing VAD Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Rate of postoperative AKI (within 5 post-op days) based on AKIN criteria
研究概览
简要总结
The investigators are doing this research to find out if more careful assessment and elimination of potential risk factors of acute kidney injury (AKI) during the subject's perioperative period will reduce their chance of kidney damage and kidney damage related problems.
详细描述
The purpose of the study is to investigate whether preventive measures for patients undergoing ventricular assist device (VAD) placement will reduce AKI occurrence, progression and associated complications.
Participants will be in the study for a total of 6 days (1 day prior to the surgery and 5 days after the surgery). The investigators will review the participant's medical record up to one year after surgery.
The study investigators will access the participant's electronic medical record 24 hours prior to the planned VAD implantation and review the participant's medication regimen and provide recommendations to the participant's primary care physician in an effort to minimize potential risks for AKI. There will be no intervention during the operation.
The clinical recommendations will cover the following:
- Avoidance of potentially nephrotoxic agents.
- Optimizing volume status (avoidance of volume overload or depletion)
- Optimizing electrolytes and acid-base status
- Minimizing IV contrast exposure when appropriate
- Treating severe anemia
- Optimization of hemodynamics (Mean arterial BP>65mmHg).
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 Undergoing Prospective VAD
Patients undergoing VAD placement. 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 postoperative AKI (within 5 post-op days) based on AKIN criteria
时间窗: 5 days after the surgery
The Acute Kidney Injury Network (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
- Severity of postoperative AKI (within 5 post-op days) based on AKIN criteria(5 days after the surgery)
- Length of hospital stay(1 year after the surgery)
- In hospital (perioperative) mortality and one-year mortality(Approximately 5 days after surgery, one year after enrollment)
研究者
Qi Qian, M.D.
Professor of Medicine and Physiology
Mayo Clinic