PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients
Purpose
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.
Conditions
- Delirium in Old Age
- Delirium
- Coronary Artery Disease
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥ 60 years of age 2. Patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery] requiring cardiopulmonary bypass
Exclusion Criteria
- Pre-operative left ventricular ejection fraction (LVEF) < than 30% 2. Emergent procedures 3. Isolated aortic surgery 4. Liver dysfunction (liver enzymes > 3 times the baseline, all patients will have a baseline liver function test information), history and exam suggestive of jaundice 5. Hypersensitivity to the study drugs 6. Active (in the past year) history of alcohol abuse (≥5 drinks per day for men or ≥ 4 drinks per day for women) 7. Any history of alcohol withdrawal or delirium tremens 8. Delirium at baseline 9. Non-English speaking 10. Prisoners 11. Physician Refusal 12. COVID-19 Positive, symptomatic 13. Co-enrollment with non-approved interventional trial
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IV Acetaminophen |
1 g IV acetaminophen every 6 hours for 48 hours during the first 2 days postoperatively |
|
|
Placebo Comparator Placebo |
Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Beth Israel Deaconess Medical Center
Detailed Description
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; 1. the incidence, duration, and severity of postoperative delirium, 2. 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 3. longer-term (one, six, 12 months) cognitive, physical, and self-care functional recovery after surgery.