Perioperative Individualized Optimization of Mean Arterial Pressure in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Complications on Day 7
研究概览
简要总结
Neurologic and renal complications frequently occur after cardiac surgery. Acute renal failure following cardiac surgery increase the risk of chronic kidney disease, while postoperative neurological complications increased the risk of chronic cognitive dysfunction. Many cardiac surgical patients suffer from systemic hypertension, but the goal in clinical practice is to maintain the mean arterial pressure (MAP) above 65 mmHg. The investigators test the hypothesis that an individualized MAP optimization during the per-operative and the 24 hours postoperative period should decrease the renal and neurological complications following cardiac surgery.
The investigators propose a randomized controlled study conducted in 21 French cardiac surgical centers. Patients scheduled for aortic or coronary by-pass without neurological or renal dysfunction could be allocated to either individualized MAP group (individualized (+/- 10% of the resting MAP measured during the preoperative anesthesiology consultation) or control group (MAP ≥ 65mmHg). In each group, the first hemodynamic time follows fluid optimization and goal directed perfusion during cardio-pulmonary by-pass to test only the MAP as objective during the peroperative and first 24 hours following surgery. The vasopressors used will be carefully protocolized using norepinephrine to objectively test the clinical interest of MAP value more than vasopressor type.
The primary objective is to assess if an individualized MAP strategy (+/- 10% of the resting MAP) conducted in per and postoperative cardiac surgery decrease a composite endpoint (mortality, neurological and/or renal complications following surgery), in comparison with a control group corresponding to the clinical routine (MAP ≥ 65 mmHg).
详细描述
Neurologic and renal complications frequently occur after cardiac surgery. Acute renal failure following cardiac surgery increase the risk of chronic kidney disease, while postoperative neurological complications increased the risk of chronic cognitive dysfunction. Many cardiac surgical patients suffer from systemic hypertension, but the goal in clinical practice is to maintain the mean arterial pressure (MAP) above 65 mmHg. The investigators test the hypothesis that an individualized MAP optimization during the per-operative and the 24 hours postoperative period should decrease the renal and neurological complications following cardiac surgery.
The investigators propose a randomized controlled study conducted in 21 French cardiac surgical centers.
Inclusion criteria :
- Age > 18 yr
- Patient scheduled for cardiac surgery with cardiopulmonary bypass (aortic valve repair or replacement and/or aortic surgery with normothermia and/or coronary artery bypass)
- Patient able to understand and voluntarily sign an informed consent form
- Patient able to adhere to the study visit schedule and other protocol requirements
- Patient affiliated with an appropriate social security system.
- French speaking patient
Exclusion criteria :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age > 18 yr
- •Patient scheduled for cardiac surgery with cardiopulmonary bypass (aortic valve repair or replacement and/or aortic surgery with normothermia and/or coronary artery bypass)
- •Patient able to understand and voluntarily sign an informed consent form
- •Patient able to adhere to the study visit schedule and other protocol requirements
- •Patient affiliated with an appropriate social security system.
- •French speaking patient
排除标准
- •Glomerular filtration rate < 30 ml/min/1.73m2
- •Neurologic disorder (motor and/or sensory deficit, cognitive disorder)
- •Another type of surgery (emergency surgery, mitral or tricuspid repair or replacement, congenital surgery)
- •Left ventricular ejection fraction < 30% or acute heart failure in the month before surgery
- •Pulmonary artery pressure > 60 mmHg
- •Endocarditis
- •Surgery with hypothermia (< 34°C)
- •Hepatic cirrhosis (Score Child-Pugh ≥ 7)
- •Alcohol use disorder (Score AUDIT C ≥ 5)
- •Refusal to consent or adults with protective measures (curatorship or tutorship or safeguarding justice or juridical protection)
- •Pregnancy or breast-feeding
结局指标
主要结局
Complications on Day 7
时间窗: On day 7
composite endpoint of mortality, neurological and/or renal complications following surgery
次要结局
- Neurological complications at day 7(On day 7)
- Renal complications at day 90(On day 90 +/- 10 days)
- Postoperative cognitive dysfunction at day 90(On day 90 +/- 10 days)
- Quality of life at day 90(On day 90 +/- 10 days)
- Mortality at day 7(On day 7)
- Mortality at day 90(On day 90 +/- 10 days)
- Renal complications at day 7(On day 7)
- Neurological complications at day 90(On day 90 +/- 10 days)
- Quality of life at day 7(On day 7)
- Postoperative cognitive dysfunction at day 7(On day 7)