Open Actively Recruiting

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

About

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 complications of cardiac surgery in older adults.

Primary Purpose
Prevention
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
60 Years
Maximum Age
N/A

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Join this Trial

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Study Stats
Protocol No.
22-000063
Category
Heart/Cardiovascular Diseases
Contact
Stephanie-Dee Sarovich
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04093219
For detailed technical eligibility, visit ClinicalTrials.gov.