NCT04093219CompletedPhase 3
PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients
PANDORA: Scheduled Prophylactic 6-hourly Intravenous Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 901 (actual)
- First submitted
- 13 Sept 2019
- Start date
- 11 Aug 2020
- Primary completion date
- 30 Mar 2026
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT04093219
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 901
- From 11 Aug 2020 to the primary completion date, 30 Mar 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Isolated aortic surgery
Other illness
- 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
- COVID-19 Positive, symptomatic
Lab values
- Pre-operative left ventricular ejection fraction (LVEF) \< than 30%
Other
- Emergent procedures
- Liver dysfunction (liver enzymes \> 3 times the baseline, all patients will have a baseline liver function test information), history and exam suggestive of jaundice
- Delirium at baseline
- Non-English speaking
- Prisoners
- Physician Refusal
- Co-enrollment with non-approved interventional trial
Who the study is looking for
- ≥ 60 years of age
- Patients undergoing cardiac surgery \[coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery\] requiring cardiopulmonary bypass
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of California, Irvine Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Yale University - Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Albert Einstein College of Medicine- Montefiore Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.