Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Acute Kidney Injury
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients undergoing cardiopulmonary bypass
- •Procedure coronary artery bypass grafting, aortic valve replacement, or both
排除标准
- •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
研究组 & 干预措施
ACUMEN guided resuscitation protocol
Fluid resuscitation and hemodynamic management will be guided by ACUMEN based off a protocol.
干预措施: Goal Directed Fluid Therapy (Other)
Standard of care resuscitation
Fluid resuscitation will be guided by standard monitors (urine output, blood loss, transesophageal echocardiography).
结局指标
主要结局
Acute Kidney Injury
时间窗: 7 days or discharge whichever occurs first
KIDIGO Criteria for AKI
Renal Biomarkers
时间窗: 48 hours postoperatively
NGAL, Hepcidin-25, and Uromodulin
次要结局
- Morbidity and Mortality(30 days)
- Blood Transfusions(From surgical incision to 48 hours postoperatively)
- Hemodynamic Support Usage(During the first 48 hours postoperatively)
- Total Fluid Administered(From initiation of surgery to 48 hours postoperatively)
- ICU Length of Stay(From admission to the intensive care unit until discharge or 20 weeks whichever comes first.)
研究者
Reney Henderson
Assistant Professor
University of Maryland, Baltimore