AKI Prevention and Early Intervention in Patients Undergoing VAD Placement
研究概览
详细说明
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).
The investigators plan to compare the results of this study with the historical data in the same patient population in the years of 7/1/2015-6/30/2017.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Minnesota
-
Rochester、Minnesota、美国、55905
- Mayo Clinic in Rochester
-
-
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:
- Adult patients that will undergo VAD placement.
- Patients able to give consent
Exclusion criteria:
- Patients on dialysis (hemodialysis or peritoneal dialysis)
- Non-elective VAD placement (VAD implantation decision made within 24 hours)
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Subjects Undergoing Prospective VAD
Patients undergoing VAD placement.
The investigators will provide clinical recommendations to the subject's primary care provider.
|
The investigators will provide clinical recommendations to the subject's primary care provider. These will be in regards to the following:
|
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 |
|---|---|---|
|
Rate of postoperative AKI (within 5 post-op days) based on AKIN criteria
大体时间：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
|
5 days after the surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Severity of postoperative AKI (within 5 post-op days) based on AKIN criteria
大体时间：5 days after the surgery
|
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
|
5 days after the surgery
|
|
Length of hospital stay
大体时间：1 year after the surgery
|
The length of hospital stay will be determined from the electronic medical record.
|
1 year after the surgery
|
|
In hospital (perioperative) mortality and one-year mortality
大体时间：Approximately 5 days after surgery, one year after enrollment
|
The number of subjects who died in hospital (perioperatively) and one year after surgery
|
Approximately 5 days after surgery, one year after enrollment
|
合作者和调查者
赞助
调查人员
- 首席研究员：Qi Qian, M.D.、Mayo Clinic
出版物和有用的链接
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
与本研究相关的术语
关键字
其他研究编号
- 17-001893
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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