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NCT04093219 · ClinicalTrials.gov registry record · Phase 3
PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients
A Phase 3 study of Coronary Artery Disease and Delirium, sponsored by Beth Israel Deaconess Medical Center.
- Active
- Registry status
- Phase 3
- Development phase
- 900
- Enrollment target
- 10
- Study locations
NCT04093219: Active Phase 3 study of Coronary Artery Disease and Delirium, sponsored by Beth Israel Deaconess Medical Center.
NCT04093219 is a Phase 3 study of Coronary Artery Disease and Delirium that is active but no longer recruiting, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 900 participants, below the 1,283-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (30% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04093219, a Phase 3 study of Coronary Artery Disease and Delirium, is active but no longer recruiting, sponsored by Beth Israel Deaconess Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 900 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
Occurrence of delirium on any postoperative day, as assessed using the CAM, 3D CAM, CAM Only, or CAM-ICU daily until hospital discharge.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2020-08-11 |
| Est. Completion | 2026-03-04 |
| Phase | Phase 3 |
What the registry record for NCT04093219 still lists
NCT04093219 is an interventional study that assigns participants to a tested intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, below the 1,283-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (30% lower).
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.
NCT04093219 lists 10 locations in 6 states (Massachusetts, California, New York).
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.
What interventions are being tested in trial NCT04093219?
The interventions under investigation include: Placebo (OTHER), IV acetaminophen (DRUG).
Who is sponsoring clinical trial NCT04093219?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04093219's enrollment target sits among peer trials
900 53rd of 219 higher than 167 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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