PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Delirium in Old Age, Delirium, Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT04093219

Run by

Beth Israel Deaconess Medical Center

People needed

900

Starts

2020-08-11

Expected to finish

2026-04-05

Last updated by the study team

2026-04-13

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 60 years of age
• Patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery] requiring cardiopulmonary bypass

You may not qualify if…

• 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
• Prisoners
• Physician Refusal
• COVID-19 Positive, symptomatic
• Co-enrollment with non-approved interventional trial

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California Irvine — Irvine, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Yale University/Yale New Haven Hospital — New Haven, Connecticut, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Albert Einstein College of Medicine- Montefiore — The Bronx, New York, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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