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ACTIVE NOT RECRUITING Phase 3

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

NCT04093219 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • OTHER Placebo
  • DRUG IV acetaminophen

Study Locations (10)

Massachusetts

  • Massachusetts General Hospital — Boston
  • Brigham and Women's Hospital — Boston
  • Beth Israel Deaconess Medical Center — Boston

California

  • University of California Irvine — Irvine
  • University of California Los Angeles — Los Angeles

New York

  • Columbia University Irving Medical Center — New York
  • Albert Einstein College of Medicine- Montefiore — The Bronx

Alabama

  • University of Alabama at Birmingham — Birmingham

Connecticut

  • Yale University/Yale New Haven Hospital — New Haven

Pennsylvania

  • University of Pittsburgh Medical Center — Pittsburgh

Trial Details

FieldValue
Enrollment Target 900 participants
Start Date 2020-08-11
Est. Completion 2026-03-04
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04093219

The ClinicalTrials.gov registry entry for NCT04093219 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 434 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04093219 reports 10 study locations spanning 6 distinct geographic areas — top geographies include Massachusetts, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04093219 about?

NCT04093219 is a clinical study titled "PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients". 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.

What is the current status of trial NCT04093219?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 900 participants. The study started on 2020-08-11. Estimated completion is 2026-03-04.

What conditions does trial NCT04093219 study?

This clinical trial studies the following conditions: Coronary Artery Disease, Delirium, Delirium in Old Age. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04093219?

The interventions under investigation include: Placebo (OTHER), IV acetaminophen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04093219?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 434 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04093219 being conducted?

This trial has 10 study locations across Alabama, California, Connecticut, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial