The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Delirium
研究概览
简要总结
The objective of this study is to test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, this trial tests the primary hypothesis that caffeine will reduce the incidence of postoperative delirium.
详细描述
Delirium is a syndrome characterized by failure of basic cognitive functions that affects approximately 20-50% of older surgical patients. Delirium during surgical recovery is associated with increased mortality, cognitive and functional decline, and prolonged hospitalization. In fact, 3-year survival rates for acutely hospitalized patients with delirium, and subsyndromal delirium, are both less than 50%. Older age is predictive of delirium after surgery, and with aging surgical populations, the incidence of postoperative delirium and related complications are likely to increase in the coming years.
Caffeine represents a novel, neurobiologically informed candidate intervention for reducing risk of early postoperative delirium. Caffeine promotes arousal via adenosine receptor antagonism and improves cognitive function concurrent with increased cortical cholinergic tone. Our preliminary data suggest that caffeine reduces risk of postanesthesia care unit (PACU) delirium in adult non-cardiac surgery patients by optimizing cortical dynamics for cognition. Caffeine also optimizes key neurocognitive processes that support information processing and may improve other, related aspects of clinical recovery, such as rebound headache in habitual caffeine users. The objective of this trial is to thus test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, the primary hypothesis is that caffeine will reduce the incidence of postoperative delirium. The secondary objectives are to (1) test whether caffeine positively impacts the quality of postoperative recovery via validated patient-reported measures and (2) identify neural correlates of delirium and Mild Cognitive Impairment via advanced electroencephalographic (EEG) analysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This will be a single-center, quadruple-blinded, randomized control trial at Michigan Medicine
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>/= 70 years old) undergoing non-cardiac, non-intracranial neurologic, non-major vascular surgery requiring general anesthesia with a planned admission for at least 48 hours.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Provision of signed and dated informed consent form.
排除标准
- •Emergency surgery
- •Outpatient surgery
- •Severe cognitive impairment precluding the capacity for informed consent
- •Seizure disorder history
- •Intolerance or allergy to caffeine (based on subjective reporting or objective documentation)
- •Weight >130 kg (as a 3 mg/kg dose would approach the upper limit of daily intake recommended by the FDA)
- •Enrollment in conflicting research study
- •Patients in acute liver failure
- •Acute kidney injury preoperatively
- •Diagnosis of pheochromocytoma
- •Active carcinoid syndrome
- •Severe audiovisual impairment
- •Non-English speaking
研究组 & 干预措施
High-dose Caffeine
Prepared intravenous high-dose caffeine citrate (3 mg/kg) at multiple postoperative time points over a 30-minute infusion period.
干预措施: Caffeine citrate (Drug)
Low-dose Caffeine
Prepared intravenous low-dose caffeine citrate (1.5 mg/kg) at multiple postoperative time points over a 30-minute infusion period.
干预措施: Caffeine citrate (Drug)
Control
Prepared intravenous piggyback solution of 5 percent dextrose water at multiple postoperative time points over a 30-minute infusion period.
干预措施: Dextrose Water (Drug)
结局指标
主要结局
Delirium
时间窗: Day of surgery through afternoon of postoperative day three
Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (CAM), and supplemented by a validated daily chart review method.
Delirium
时间窗: Day of surgery through afternoon of postoperative day three
Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (CAM), and supplemented by a validated daily chart review method.
次要结局
- Sedation(Preoperative baseline through postoperative day three afternoon)
- Cumulative Opioid Consumption(Day of surgery through postoperative day three afternoon)
- Delirium Severity(Day of surgery through afternoon of postoperative day three)
- Delirium Duration(Day of surgery through afternoon of postoperative day three)
- Patient-Reported Quality of Recovery(Preoperative baseline through postoperative day three afternoon)
- Agitation(Preoperative baseline through postoperative day three afternoon)
- Headache(Preoperative baseline through postoperative day three afternoon)
研究者
Phillip Vlisides
Assistant Professor of Anesthesiology
University of Michigan