Active Temperature Management After Cardiac Surgery and Its Effect on Postoperative Cognitive Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in cognitive Function post CABG
研究概览
简要总结
This study will assess the effect of active postoperative temperature management and its effect on the cognitive function in patients following coronary artery bypass graft (CABG) surgery to determine if active postoperative temperature management to maintain normothermia reduces postoperative cognitive dysfunction (POCD) in this population. Additionally, the investigators will explore differences in temperature control variability by using temperature management wraps combined with acetaminophen vs. acetaminophen alone in a pilot arm.
详细描述
As one of the more common hospital-based major interventional procedures, 180,476 CABG surgeries were performed in the United States in 2016, according to the Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS ACSD). Of these, 23,545 operations also involved aortic or mitral valve repair or replacement. The demographic characteristics of patients undergoing cardiac surgery have changed over time, with a higher proportion of elderly patients undergoing increasingly complex procedures. The number of patients with neurological disease prior to surgery has nearly doubled from 1.4% in 2001 to nearly 2.8% as of 2010, and is rising as surgical care improves and includes more such patients .
The recognition of neurological complications associated with cardiac surgery has been report-ed widely, and neurological dysfunction can be categorized as type 1 (brain death, non-fatal stroke, and new transient ischemic attack) or type 2 (delirium and postoperative cognitive dys-function) . The incidence postoperative neurological complications, defined as "permanent stroke" by the STS ACSD, was noted in 2016 to be 1.3% following isolated CABG operations, but was noted to be higher, between 2-3% in CABG patients also receiving aortic or mitral valve surgery as part of their operation. Notably, this statistic does not capture POCD, although steps are being taken to better capture this, perhaps as a patient-reported outcome (PRO) in the future.
As early as 1955, POCD was described by Bedford in the Lancet under the designation "adverse cerebral effects of anesthesia on old people" . It can affect any age group, but does seem to dis-proportionately affect patients age 60 or older, causing difficulty in daily life and their ability to return to work . Short-term POCD, up to 6 weeks postoperatively, occurs in 20-50% of patients undergoing cardiac surgery. Longer-term POCD, defined as a subtle deterioration in cognitive function 6 months following surgery, occurs in 10-30% of cardiac surgery patients . In a longitudinal study with 8.5 years of follow-up, Steinmetz et al. found POCD to be associated with higher mortality (Cox proportional hazard ratio 1.63, 95% confidence interval 1.11-2.38; p = 0.01), earlier retirement, and greater utilization of social financial assistance . Monk et al. found that the risk of death within one year was greater among patients who had POCD when they were discharged from the hospital .
CABG and valve surgery most commonly use the extracorporeal cardiopulmonary bypass machine to perfuse the body during cardiac surgery. The aorta is cross-clamped to allow work and suturing in a near bloodless field. The major blood branches to the brain come off the aorta. When the aorta is cross-clamped, the brain undergoes a period of ischemia. While the patient is on bypass, the body and brain are kept at low temperatures to quell the effects of ischemia. Temperature elevation has been proposed to have an all-or-none response with a defined threshold beyond which the increased temperature aggravates ischemic injury. Hyperthermia leads to physiological and structural changes in the brain which include alterations of enzyme activity and damage to cytoskeletal proteins found in the brain. In addition, hyperthermia causes a release of excitatory neurotransmitters, the production of free radicals, an increase in blood-brain barrier permeability, and increase in intracellular acidosis after ischemic reperfusion all of which have all been proposed as mechanisms through which hyperthermia leads to brain tissue injury and can exacerbate ischemic brain injury .
Intraoperative temperature during cardiac surgery has long been thought to have an association with postoperative neurological outcomes, and has been well studied. In mitigating neuroinflammation and subsequent brain injury, intraoperative hypothermia as compared with normothermia has been the subject of much debate, and outcomes have varied considerably in various studies. The process of rewarming patients as they gradually disengage from cardiopulmonary bypass has been noted as another important process in modulating neuroprotection, and has al-so been studied extensively. Nearly all studies have associated a slower rate of intraoperative rewarming with a decreased incidence of POCD.
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
- 20 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled coronary artery bypass graft surgery patients, with or without valve surgery
- •patients able to give informed consent
排除标准
- •age < 20 years or > 89 years
- •patients with unscheduled CABG +/- valve surgery (i.e. emergency surgery)
- •deformity or skin condition of chest or thighs that would interfere with the successful placement of Rapr Round® vest and leg wraps
- •patients presenting to the ICU postoperatively with a fever ≥ 38.3
- •patients with planned intraoperative circulatory arrest
- •pregnant patients
- •patients with symptomatic cerebrovascular disease, specifically residual motor deficits, expressive or receptive aphasia from prior stroke or cerebrovascular accident
研究组 & 干预措施
Tylenol
This group will receive the standard of care of monitoring temperature and administering Tylenol if a fever develops.
干预措施: Acetaminophen (Drug)
Body wrap
This group will receive the body wraps post surgery to maintain normothermia.
干预措施: Rapr Rounds Hyper/Hypothermia Wraps (Device)
Tylenol with body wrap
This group will receive the standard of care of monitoring temperature but will be administered Tylenol and body wraps if a fever develops.
干预措施: Rapr Rounds Hyper/Hypothermia Wraps (Device)
Tylenol with body wrap
This group will receive the standard of care of monitoring temperature but will be administered Tylenol and body wraps if a fever develops.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Change in cognitive Function post CABG
时间窗: From pre surgery and 6 weeks post surgery
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) administered by a clinical psychologist or re-searcher specifically trained by the clinical psychologist. The RBANS is a screening tool that has been standardized to measure the neu-ropsychological status of adult patient between the ages of 20 and 89. It is composed of 12 sub-tests and takes approximately 30 minutes to administer. It is scored using a scaled index score from 40 to 160 with the following score ranges: 130 and above: very superior 120-129: superior 110-119: high average 90-109: average 80-89: low average 70-79: borderline 69 and below: extremely low
次要结局
- Variability in Temperature(Up to 24 hours post surgery)
