TerminatedPhase 2

The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery

Stopped: Unable to find a sufficient number of suitable study patients.

United States1 participantsStarted 2026-03-03

Plain-language summary

The purpose of this study is to determine whether giving omega-3 fatty acids prior to and after cardiac bypass surgeries decreases the incidence of postoperative delirium in patients aged 65 and over.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 65 years * American Society of Anesthesiologists (ASA) Class Physical Status I-IV Exclusion Criteria: * Inability to obtain written informed consent. * Inability to take study drug due to intubation or other reason. * Delirium present at screening. * Known hypersensitivity (e.g. anaphylactic reaction) to omega-3 ethyl esters or any of its components * Allergy to fish or shellfish * Currently taking warfarin (Coumadin), apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa/Lixiana), rivaroxaban (Xarelto), or other anticoagulant drugs. * Currently taking omega-3, omega-6, vitamin E, or fish oil supplements. * Significant renal disease with a serum creatinine ≥ 2 mg/dL. * Significant liver disease with alanine aminotransferase (ALT) levels 1.5 times the normal range of 6-45 units/liter and aspartate transferase (AST) levels 1.5 times the normal range of 10-42 units/liter. * History or diagnosis of diabetes. * History or diagnosis of neurodegenerative disease such as Parkinson's, Alzheimer's, or dementia. * History or diagnosis of bleeding disorder. * History or diagnosis of metabolic syndrome or disorder. * History or diagnosis of thyroid problems such as hyperthyroidism or hypothyroidism.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence of Postoperative Delirium

Timeframe: From the date of surgery until the patient is discharged, up to 30 days.

Trial details

NCT IDNCT06434948

SponsorUniversity of Missouri-Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-29

View on ClinicalTrials.gov More Postoperative Delirium trials

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.