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Analgesic

IV Acetaminophen for Delirium After Cardiac Surgery (PANDORA Trial)

Phase 3

Recruiting

Led By Balachundhar Subramaniam, MD, MPH

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 60 years of age

Patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery] requiring cardiopulmonary bypass

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month, 6 month and 1- year following the date of surgery

Awards & highlights

PANDORA Trial Summary

This trial is testing if IV acetaminophen can reduce postoperative delirium in older adults after cardiac surgery.

Who is the study for?

This trial is for adults aged 60 or older who are undergoing certain types of cardiac surgery with cardiopulmonary bypass. It's not suitable for prisoners, COVID-19 positive individuals, those needing urgent procedures, non-English speakers, patients with severe heart or liver issues, a recent history of alcohol abuse, or anyone already experiencing delirium.Check my eligibility

What is being tested?

The PANDORA study is testing whether IV acetaminophen can prevent postoperative delirium—a common complication after cardiac surgery in older patients—compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo.See study design

What are the potential side effects?

While specific side effects aren't listed here, IV acetaminophen generally may cause reactions at the injection site, nausea, headache, insomnia and constipation. Rarely it could lead to serious skin reactions or liver damage.

PANDORA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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I am having heart surgery that needs a heart-lung machine.

PANDORA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be followed at 1 month, 6 month and 1- year following the date of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be followed at 1 month, 6 month and 1- year following the date of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed at 1 month, 6 month and 1- year following the date of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of postoperative delirium

Secondary outcome measures

Additional postoperative analgesic requirements

Duration of delirium

Incidence of Charted Delirium

+10 more

Other outcome measures

Discontinuation of study drug

Liver Function Tests

Side effects data

From 2015 Phase 4 trial • 41 Patients • NCT01721486

vomit x1

coughing

headache

stridor

100%

80%

60%

40%

20%

Study treatment Arm

Study Group

Control Group

PANDORA Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IV AcetaminophenExperimental Treatment1 Intervention

1 g IV acetaminophen every 6 hours for 48 hours during the first 2 days postoperatively

Group II: PlaceboPlacebo Group1 Intervention

Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IV acetaminophen

2013

Completed Phase 4

~1490

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

836 Previous Clinical Trials

13,009,436 Total Patients Enrolled

9 Trials studying Delirium

1,753 Patients Enrolled for Delirium

National Institute on Aging (NIA)NIH

1,669 Previous Clinical Trials

28,004,214 Total Patients Enrolled

35 Trials studying Delirium

37,729 Patients Enrolled for Delirium

Balachundhar Subramaniam, MD, MPHPrincipal Investigator - Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center

7 Previous Clinical Trials

8,936 Total Patients Enrolled

2 Trials studying Delirium

162 Patients Enrolled for Delirium

Media Library

IV acetaminophen (Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT04093219 — Phase 3

Delirium Research Study Groups: Placebo, IV Acetaminophen

Delirium Clinical Trial 2023: IV acetaminophen Highlights & Side Effects. Trial Name: NCT04093219 — Phase 3

IV acetaminophen (Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04093219 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared IV acetaminophen for use?

"There is both clinical evidence and multiple rounds of supportive data that confirm IV acetaminophen's safety, giving it a score of 3."

Answered by AI

Is this the first time IV acetaminophen has been trialed?

"Acetaminophen given intravenously was first studied in 2007 at Vanderbilt University Medical Center. So far, there have been 18,796 completed clinical trials. Right now, 98 clinical trials are ongoing, with a high concentration in Boston, Massachusetts."

Answered by AI

Are there different research centers across North America testing this new medication?

"So far, 8 medical institutions have signed up to run this clinical trial. They are Beth Israel Deaconess Medical Center in Boston, Yale University/Yale New Haven Hospital in New Haven, and University of Alabama at Birmingham in Birmingham. 5 other locations are also participating."

Answered by AI

How many individuals can sign up for this clinical trial at most?

"In order to meet the requirements of this clinical trial, 900 willing and eligible participants are needed. This study is conducted at Beth Israel Deaconess Medical Center in Boston, MA and Yale University/Yale New Haven Hospital in New Haven, CT."

Answered by AI

Are there any spaces left in this research for new participants?

"Yes, this information is accurate according to the listing on clinicaltrials.gov. This particular trial was posted on August 11th, 2020 and was last updated on June 15th, 2022."

Answered by AI