CompletedPhase 3

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

United States900 participantsStarted 2020-08-11

Plain-language 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.

Who can participate

Age range60 Years

SexALL

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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

What they're measuring

Incidence of postoperative delirium

Timeframe: Participants will be followed for the duration of the hospital stay, an average of 5 days

Trial details

NCT IDNCT04093219

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-30

View on ClinicalTrials.gov More Delirium in Old Age trials