PANDORA: Scheduled Prophylactic 6-hourly Intravenous Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 18
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
Our objective is to find an effective prophylactic intervention by evaluating IV acetaminophen's impact in reducing the frequency of postoperative delirium, one of the most common and detrimental complications of cardiac surgery in older adults.
详细描述
This project will study the impact of scheduled administration of IV acetaminophen on the incidence, duration, and severity of postoperative delirium and other important hospital outcomes. Additionally, this trial will evaluate the effects of IV acetaminophen on longer-term postoperative cognitive dysfunction and functional status and develop a biorepository of perioperative samples as a future resource to probe the mechanisms of postoperative delirium.
The investigators propose three specific aims by conducting a randomized, triple-blind clinical trial that enrolls 900 patients 60 years of age or older undergoing cardiac surgery. Through this trial, the investigators will determine the effect of IV acetaminophen on;
- the incidence, duration, and severity of postoperative delirium,
- the use of opioids and other rescue analgesics in the first 48 postoperative hours, daily pain scores at rest and exertion, and length of stay in the Intensive Care Unit and overall hospital length of stay
- longer-term (one, six, 12 months) cognitive, physical, and self-care functional recovery 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)
盲法说明
The research pharmacists at each institution will prepare the placebo and will dispense the study drug according to treatment allocation. Treatment allocation will otherwise remain concealed from all others involved in the conduct and analysis of the trial, including those performing statistical analysis. Study participants will remain blinded throughout.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 60 years of age
- •Patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery] requiring cardiopulmonary bypass
排除标准
- •Pre-operative left ventricular ejection fraction (LVEF) < than 30%
- •Emergent procedures
- •Isolated aortic surgery
- •Liver dysfunction (liver enzymes > 3 times the baseline, all patients will have a baseline liver function test information), history and exam suggestive of jaundice
- •Hypersensitivity to the study drugs
- •Active (in the past year) history of alcohol abuse (≥5 drinks per day for men or ≥ 4 drinks per day for women)
- •Any history of alcohol withdrawal or delirium tremens
- •Delirium at baseline
- •Non-English speaking
- •Physician Refusal
- •COVID-19 Positive, symptomatic
- •Co-enrollment with non-approved interventional trial
研究组 & 干预措施
IV Acetaminophen
1 g IV acetaminophen every 6 hours for 48 hours during the first 2 days postoperatively
干预措施: IV acetaminophen (Drug)
Placebo
Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: Participants will be followed for the duration of the hospital stay, an average of 5 days
Occurrence of delirium on any postoperative day, as assessed using the CAM, 3D CAM, CAM Only, or CAM-ICU daily until hospital discharge.
次要结局
- Length of stay in the Intensive Care Unit (ICU)(Measured in days admitted in the ICU, an average of 2 days)
- Additional postoperative analgesic requirements(First 48 hours postoperatively)
- Duration of delirium(Participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month, 6 month and 1- year following the date of surgery)
- Time to onset of delirium(Participants will be followed for the duration of the hospital stay, an average of 5 days)
- Worst daily pain scores at rest(Participants will be followed for the duration of the hospital stay, an average of 5 days)
- Trajectory of cognitive function over time(Participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month, 6 month and 1- year following the date of surgery)
- Incidence of Charted Delirium(Participants will be followed for the duration of the hospital stay, an average of 5 days)
- Severity of delirium(Participants will be followed for the duration of the hospital stay, an average of 5 days)
- Worst daily pain scores with exertion (deep breathing and cough)(Participants will be followed for the duration of the hospital stay, an average of 5 days)
- Trajectory of physical function over time.(Participants will be followed at 1 month, 6 month and 1- year following the date of surgery)
- Trajectory of chronic pain over time(Participants will be followed at 6 month and 1- year following the date of surgery)
- Trajectory of functional outcomes over time(Participants will be followed at 1 month, 6 month and 1- year following the date of surgery)
- Length of hospital stay(Measured in days admitted in the hospital, an average of 6 days)
研究者
Balachundhar Subramaniam
Associate Professor of Anesthesia
Beth Israel Deaconess Medical Center