Lidocaine For Neuroprotection During Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- Count of Participants With a Decline of Greater Than or Equal to One Standard Deviation in One or More of Five Cognitive Domain Scores Reported as a Dichotomous Post-operative Cognitive Deficit (POCD) Outcome
研究概览
简要总结
The purpose of this study is to see if a drug called lidocaine prevents cognitive injury (a decline in mental abilities) after heart surgery. Lidocaine is currently FDA approved and is commonly used for treating some heart rhythm disorders and for regional anesthesia (blocking nerves). The investigators are enrolling subjects in this research project to see if lidocaine will reduce the high incidence of cognitive injury seen after heart surgery. As part of this study, the investigators will also evaluate the relationship between cognitive injury and genetic makeup and the chemical changes in the subjects blood during and after surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CABG, CABG + Valve, or Valve surgery
- •Use of cardiopulmonary bypass
排除标准
- •Less than 50 years of age
- •History of diabetes
- •History of symptomatic cerebrovascular disease (e.g. prior stroke) with residual deficit
- •Alcoholism (> 2 drinks/day)
- •History of psychiatric illness (any clinical diagnoses requiring therapy)
- •History of drug abuse (any illicit drug use in the past 3 months)
- •Hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)
- •Severe pulmonary insufficiency (requiring home oxygen therapy)
- •Renal failure (baseline serum creatinine > 2.0 mg/dl)
- •Pregnant women
- •Unable to read and thus unable to complete the cognitive testing
- •Score < 24 on a baseline Mini Mental State examination (MMSE) or greater than or equal to 27 on the baseline Center for Epidemiological Studies Depression (CES-D) Scale -
研究组 & 干预措施
Lidocaine
Lidocaine infusion for 48 hours
干预措施: Lidocaine (Drug)
Placebo
Normal saline infusion for 48 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Count of Participants With a Decline of Greater Than or Equal to One Standard Deviation in One or More of Five Cognitive Domain Scores Reported as a Dichotomous Post-operative Cognitive Deficit (POCD) Outcome
时间窗: Preoperative to 6 weeks after surgery
To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. Each domain score is normally distributed with a mean of zero. A change score was calculated for each domain by subtracting the baseline from the 6-week score. A dichotomous outcome variable of post-operative cognitive deficit was defined as a decline of ≥1 standard deviation in 1 or more of the 5 domains.
Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change
时间窗: Preoperative to 6 weeks after surgery
To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement.
次要结局
- Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)(baseline, 1-year)
- Change in Center for Epidemiological Studies Depression Scale (CES-D)(baseline, 1-year)
- Change in Spielberger State Anxiety Inventory (STAI)(baseline, 1-year)
- Change in Symptom Limitations(baseline, 1-year)
- Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)(baseline, 1-year)
- Transcerebral Activation Gradients of Platelets(Baseline to 6 hours post cross-clamp removal)
- Transcerebral Activation Gradients of Neutrophils(Baseline to 6 hours post cross-clamp removal)
- Transcerebral Activation Gradient of Platelet-neutrophil Conjugates(Baseline to 6 hours post cross-clamp removal)
- Change in Cognitive Function From Baseline(1 year after surgery)
- Change in Duke Activity Status Index (DASI)(baseline, 1-year)
- Transcerebral Activation Gradients of Monocytes(Baseline to 6 hours post cross-clamp removal)
- Change in the Cognitive Difficulties Scale(baseline, 1-year)
- Change in Perceived Social Support(baseline, 1-year)
- Change in Social Activity(baseline, 1-year)
- Change in Study 36-Item Short Form Health Survey (SF-36)(baseline, 1-year)
- Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)(baseline, 1-year)