Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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

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 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The research pharmacists at each institution will prepare the placebo and will dispense the study drug according to treatment allocation. Treatment allocation will otherwise remain concealed from all others involved in the conduct and analysis of the trial, including those performing statistical analysis. Study participants will remain blinded throughout.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IV Acetaminophen
1 g IV acetaminophen every 6 hours for 48 hours during the first 2 days postoperatively
  • Drug: IV acetaminophen
    use of IV tylenol for pain
    Other names:
    • ofirmev
Placebo Comparator
Placebo
Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl
  • Other: Placebo
    Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Jean-Francois Pittet, MD
205-996-4755
jpittet@uabmc.edu

More Details

Status
Recruiting
Sponsor
Beth Israel Deaconess Medical Center

Study Contact

Balachundhar Subramaniam, MD, MPH
617-754-2721
bsubrama@bidmc.harvard.edu

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. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.