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

Last updated: April 3, 2025
Sponsor: Beth Israel Deaconess Medical Center
Overall Status: Active - Not Recruiting

Phase

3

Condition

Coronary Artery Disease

Chest Pain

Dementia

Treatment

IV acetaminophen

Placebo

Clinical Study ID

NCT04093219
2019-P-000758
R01AG065554
  • Ages > 60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥ 60 years of age

  2. Patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) with orwithout valve, isolated valve surgery] requiring cardiopulmonary bypass

Exclusion

Exclusion Criteria:

  1. 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 abaseline 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 ≥ 4drinks 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

Total Participants: 900
Treatment Group(s): 2
Primary Treatment: IV acetaminophen
Phase: 3
Study Start date:
August 11, 2020
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of California Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • Yale University/Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Albert Einstein College of Medicine- Montefiore

    Bronx, New York 10467
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

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