Status:
ACTIVE_NOT_RECRUITING
PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Delirium in Old Age
Delirium
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief 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 comp...
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. Additionall...
Eligibility Criteria
Inclusion
- ≥ 60 years of age
- Patients undergoing cardiac surgery \[coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery\] requiring cardiopulmonary bypass
Exclusion
- 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
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04093219
Start Date
August 11 2020
End Date
March 1 2026
Last Update
April 6 2025
Active Locations (10)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of California Irvine
Irvine, California, United States, 92697
3
University of California Los Angeles
Los Angeles, California, United States, 90095
4
Yale University/Yale New Haven Hospital
New Haven, Connecticut, United States, 06510