The Importance of Mean Arterial Pressure During Cardiopulmonary Bypass to Prevent Cerebral Complications After Cardiac Surgery - a Randomised Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Total volume of new ischemic cerebral lesions
研究概览
简要总结
STUDY HYPOTHESIS
In cardiac surgery the volume of perioperative cerebral infarctions can be reduced by increasing mean arterial pressure (MAP) during the cardiopulmonary bypass procedure.
BRIEF STUDY SUMMARY
Heart surgery using cardiopulmonary bypass (CPB) can be complicated by injury to the brain. Previous studies using brain scans have reported small stroke-like lesions in up to 51% of patients after cardiac surgery. However, only 1-6 % of patients have permanent symptoms of severe brain damage.
The majority of brain lesions seem to be caused by particulate matter (emboli) that wedge in blood vessels of the brain thereby compromising flow. In addition, insufficient blood flow to areas of the brain supplied by narrowed, calcified vessels may contribute. MAP during CPB usually stabilizes below the lower limit of cerebral autoregulation, which is accepted since sufficient total blood flow is guaranteed during CPB.
The aim of the PPCI trial is to investigate if increased MAP during CPB can prevent or reduce the extent of brain injury after cardiac surgery. A beneficial effect could result from reduced embolic injury through increased blood flow in collateral vessels and/or by increased blood flow in calcified arteries.
180 patients scheduled for cardiac surgery will be randomly allocated to increased MAP (70-80 mm Hg) or 'usual practice' (typically 45-50 mm Hg) during CPB, whereas CPB blood flow is intended equal and fixed in the two groups. Patients are examined before and 3-6 days after surgery with magnetic resonance imaging (MRI) brain scans, mental tests and by blood borne markers of brain injury.
If higher MAP during CPB is beneficial, a change of practice can easily be implemented in the clinical routine.
详细描述
TRIAL DESIGN
The PPCI trial is a randomized, controlled, outcomes assessor and patient blinded, single-center superiority trial with two parallel groups in a 1:1 allocation ratio. The randomization will be stratified according to age (stratum 1 < 70 years; stratum 2 ≥ 70 years) and type of surgery (stratum 1 - surgery involving the aortic and/or mitral valve; stratum 2 - surgery not involving these valves).
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
- Double (Participant, Outcomes Assessor)
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
- •≥ 18 years of age.
- •scheduled elective or subacute cardiac surgery with the use of CPB.
- •type of surgery either coronary artery bypass grafting (CABG) and/or heart valve surgery (provided that the valve prosthesis used is MRI compatible).
排除标准
- •a history of stroke.
- •a history of reversible ischemic deficits (duration of symptoms 24-72 hours)
- •a history of transitory ischemic attacks (duration of symptoms < 24 hours)
- •diagnosis of neurodegenerative disorders such as Alzheimers, Multiple Sclerosis etc.
研究组 & 干预措施
Increased bloodpressure during CPB
The cardiopulmonary bypass (CPB) procedure is conducted according to department guidelines with the modification that MAP is kept between 70 and 80 mm Hg. This is achieved by refract intravenous doses of phenylephrine to a total maximum of 2.0 mg, and after that continuous intravenous infusion of norepinephrine up to 0.4 μg/kg/min if necessary.
干预措施: Increased bloodpressure during CPB. (Procedure)
Regular bloodpressure during CPB
The cardiopulmonary bypass (CPB) procedure is conducted in accordance with departmental guidelines, where MAP is sought to be ≥ 45 mm Hg. This is achieved by refract intravenous doses of phenylephrine to a total maximum of 2.0 mg, and after that continuous intravenous infusion of norepinephrine up to 0.4 μg/kg/min if necessary.
结局指标
主要结局
Total volume of new ischemic cerebral lesions
时间窗: 6 days
The total volume of new ischemic cerebral lesions (sum in mL) assessed by diffusion-weighed-magnetic resonance imaging conducted preoperatively and again once postoperatively on day 3 to 6. The analysis will be adjusted for the randomization stratification variables age and type of surgery.
次要结局
- Near Infrared Spectroscopy (NIRS) - lowest value(End of surgery)
- Near Infrared Spectroscopy (NIRS) - total time below 25% of the baseline value on right and left side(End of surgery)
- Total number of new ischemic cerebral lesions(6 days)
- Magnetic resonance spectroscopy - change from baseline N-acetylaspartate-creatine (NAA/Cr) ratio at day 6(6 days)
- Magnetic resonance spectroscopy - change from baseline MRS Choline-creatine (Cho/Cr ratio) at day 6(6 days)
- Postoperative cognitive dysfunction (POCD) - change from baseline neuropsychological test performance at day 5-8(5-8 days)
- Postoperative cognitive dysfunction (POCD) - change from baseline neuropsychological test performance at 3 months(3 months)
- Peak value of biochemical markers of brain injury(Prior to surgery on day 1 and 24 hours, 48 hours and 6 days after surgery)
- Change from baseline performance at neurological examination day 6(6 days)
研究者
Jens C. Nilsson
Consultant, MD, PhD
Rigshospitalet, Denmark