Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 2
- 主要终点
- Acute kidney injury
研究概览
简要总结
The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass.
详细描述
Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass for cardiac surgery are both considered standard of care and allow surgeons to operate on the heart without movement. Pulsatile cardiopulmonary bypass produces variations in blood flow to produce a pulse similar to a normal beating heart. Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass are approved as safe and effective ways to provide perfusion during cardiac surgery, but it is unknown whether there are differences in clinical outcomes after surgery. Acute kidney injury is common after cardiac surgery and may be caused by inadequate perfusion during cardiopulmonary bypass.
Specific Aim: The purpose of this study is to determine the effectiveness of pulsatile blood flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.
Hypothesis
Pulsatile blood flow during cardiopulmonary bypass will reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Scheduled for elective cardiac surgery with cardiopulmonary bypass
- •Exclusion Criteria
- •Emergency procedures
- •Scheduled for heart or lung transplantation
- •Scheduled for ventricular assist device implantation
- •Use of the Medtronic Elongated Once-Piece Arterial Cannula
- •Diagnosed with sepsis
- •Diagnosed with delirium
- •Experiencing hemodynamic instability (heart rate > 100 and systolic blood pressure < 90)
- •Requiring mechanical circulatory support
- •Requiring vasoactive medications
排除标准
- 未提供
结局指标
主要结局
Acute kidney injury
时间窗: From intensive care unit admission after surgery up to 7 days
Stage 1 (mild), 2 (moderate), or 3 (severe) acute kidney injury according to the Kidney Disease Improving Global Outcomes creatinine criteria (stage 1 = 1.5 to 1.9 times baseline or greater than or equal to 0.3 milligrams per deciliter increase in serum creatinine, stage 2 = 2.0 to 2.9 times baseline in serum creatinine, stage 3 = 3.0 times baseline or increase in serum creatinine greater than or equal to 4.0 milligrams per deciliter or initiation of renal replacement therapy
次要结局
- Acute kidney injury risk score(On admission to the intensive care unit after surgery up to 24 hours after intensive care unit arrival)
- Red blood cell units transfused(After cardiopulmonary bypass up to 24 hours after intensive care unit arrival)
- Platelet nadir(On admission to the intensive care unit after surgery up to 7 days)
- 30-day mortality(From intensive care unit admission after surgery to hospital discharge, up to 30 days)
- Discontinuation rate of cardiopulmonary bypass mode(During cardiopulmonary bypass)