心脏手术中 Acumen 指导液体管理后的早期生物标志物肾损伤评估 (BE-KIND)
This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients and its impact on cardiac surgery-induced kidney injury.
研究概览
详细说明
This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients undergoing a CABG, AVR, or CABG/AVR. Kidney injury biomarkers NGAL, Uromodulin, and Hepcidin-25 will be used to assess cardiac-induced kidney injury. Patients will be randomly enrolled in either standard care for fluid management or goal-directed fluid management with ACUMEN.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Reney A Henderson, MD
- 电话号码：4103283961
- 邮箱：rhenderson@som.umaryland.edu
研究联系人备份
- 姓名：LaToya Stubbs
- 电话号码：4103289951
- 邮箱：lstubbs@som.umaryland.edu
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 undergoing cardiopulmonary bypass
- Procedure coronary artery bypass grafting, aortic valve replacement, or both
Exclusion Criteria:
- Patients < 18 years old
- Emergent surgery
- Preoperative kidney disease (Cr > 2.0 or on renal replacement therapy)
- Ejection fraction < 40%
- Incomplete data in medical record
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ACUMEN guided resuscitation protocol
Fluid resuscitation and hemodynamic management will be guided by ACUMEN based off a protocol. |
Fluid administration and hemodynamic management guided with the assistance of Edwards Lifesciences ACUMEN monitor |
|
无干预：Standard of care resuscitation
Fluid resuscitation will be guided by standard monitors (urine output, blood loss, transesophageal echocardiography). |
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 |
|---|---|---|
|
Acute Kidney Injury
大体时间：7 days or discharge whichever occurs first
|
KIDIGO Criteria for AKI |
7 days or discharge whichever occurs first
|
|
Renal Biomarkers
大体时间：48 hours postoperatively
|
NGAL, Hepcidin-25, and Uromodulin |
48 hours postoperatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Fluid Administered
大体时间：From initiation of surgery to 48 hours postoperatively
|
intraoperative and postoperative volume given measured in milliliters |
From initiation of surgery to 48 hours postoperatively
|
|
ICU Length of Stay
大体时间：From admission to the intensive care unit until discharge or 20 weeks whichever comes first.
|
Quantified in days and hours |
From admission to the intensive care unit until discharge or 20 weeks whichever comes first.
|
|
Hemodynamic Support Usage
大体时间：During the first 48 hours postoperatively
|
Vasopressor or Inotrope usage |
During the first 48 hours postoperatively
|
|
Morbidity and Mortality
大体时间：30 days
|
Death and Major adverse events (cerebral vascular stroke, myocardial infarction, infection, prolonged intubation > 24 hours) |
30 days
|
|
Blood Transfusions
大体时间：From surgical incision to 48 hours postoperatively
|
Any Allogeneic Blood Transfusions |
From surgical incision to 48 hours postoperatively
|
合作者和调查者
调查人员
- 首席研究员：Reney A Henderson, MD、University of Maryland, Baltimore
出版物和有用的链接
一般刊物
- Nadim MK, Forni LG, Bihorac A, Hobson C, Koyner JL, Shaw A, Arnaoutakis GJ, Ding X, Engelman DT, Gasparovic H, Gasparovic V, Herzog CA, Kashani K, Katz N, Liu KD, Mehta RL, Ostermann M, Pannu N, Pickkers P, Price S, Ricci Z, Rich JB, Sajja LR, Weaver FA, Zarbock A, Ronco C, Kellum JA. Cardiac and Vascular Surgery-Associated Acute Kidney Injury: The 20th International Consensus Conference of the ADQI (Acute Disease Quality Initiative) Group. J Am Heart Assoc. 2018 Jun 1;7(11):e008834. doi: 10.1161/JAHA.118.008834. No abstract available.
- Kullmar M, Massoth C, Ostermann M, Campos S, Grau Novellas N, Thomson G, Haffner M, Arndt C, Wulf H, Irqsusi M, Monaco F, Di Prima A, Garcia Alvarez M, Italiano S, Cegarra SanMartin V, Kunst G, Nair S, L'Acqua C, Hoste EAJ, Vandenberghe W, Honore PM, Kellum J, Forni L, Grieshaber P, Weiss R, Gerss J, Wempe C, Meersch M, Zarbock A. Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial. BMJ Open. 2020 Apr 6;10(4):e034201. doi: 10.1136/bmjopen-2019-034201.
- Vives M, Hernandez A, Parramon F, Estanyol N, Pardina B, Munoz A, Alvarez P, Hernandez C. Acute kidney injury after cardiac surgery: prevalence, impact and management challenges. Int J Nephrol Renovasc Dis. 2019 Jul 2;12:153-166. doi: 10.2147/IJNRD.S167477. eCollection 2019.
- Van den Eynde J, Schuermans A, Verbakel JY, Gewillig M, Kutty S, Allegaert K, Mekahli D. Biomarkers of acute kidney injury after pediatric cardiac surgery: a meta-analysis of diagnostic test accuracy. Eur J Pediatr. 2022 May;181(5):1909-1921. doi: 10.1007/s00431-022-04380-4. Epub 2022 Jan 17.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
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
其他相关的 MeSH 术语
其他研究编号
- HP-00100950
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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