Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at UC Irvine UCLA
Dates
study started
completion around

Description

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.

Official Title

PANDORA: Scheduled Prophylactic 6-hourly Intravenous Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients

Details

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.

Keywords

Delirium in Old Age, Delirium, Coronary Artery Disease, Acetaminophen, Postoperative, Cardiac Surgery, Emergence Delirium, IV acetaminophen

Eligibility

You can join if…

Open to people ages 60 years and up

  1. ≥ 60 years of age
  2. Patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery] requiring cardiopulmonary bypass

You CAN'T join if...

  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 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

Locations

  • University of California Irvine not yet accepting patients
    Irvine California 92697 United States
  • University of California Los Angeles not yet accepting patients
    Los Angeles California 90095 United States
  • University of Alabama at Birmingham accepting new patients
    Birmingham Alabama 35233 United States
  • University of Pittsburgh Medical Center accepting new patients
    Pittsburgh Pennsylvania 15213 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Beth Israel Deaconess Medical Center
ID
NCT04093219
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 900 study participants
Last Updated