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TerminatedNCT06434948Updated May 11, 2026

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

A Phase 2 interventional study of Omega-3 Ethyl Esters 4 g and Omega-3 Ethyl Esters 2 g in Postoperative Delirium, sponsored by University of Missouri-Columbia. Terminated at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by University of Missouri-Columbia · Phase 2, Interventional, and Prevention

Why this study was terminated
Unable to find a sufficient number of suitable study patients.
Phase
Phase 2
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the detailed description

Patients aged 65 years and over requiring elective cardiac bypass surgeries will receive either 0, 2, or 4 grams of omega-3 ethyl esters before their surgery and for 3 days postoperatively to determine whether there is an affect on the incidence of postoperative delirium. All patients will receive hospital standard of care therapy for their surgery and hospital stay.

02

Conditions studied

  • Postoperative Delirium

Keywords

  • postoperative delirium
  • delirium
  • fish oil
  • omega 3
  • Lovaza
  • cardiac bypass
  • omega 3 ethyl esters
03

In context

Emergence Delirium

763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.

This study's enrollment of 1 is below the median of 120 across 475 interventional studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 65 years
  • American Society of Anesthesiologists (ASA) Class Physical Status I-IV

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Omega-3 Ethyl Esters 4 g

    Patients will be given 4 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.

    Drug: Omega-3 Ethyl Esters 4 g

  • Experimental
    Omega-3 Ethyl Esters 2 g

    Patients will be given 2 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.

    Drug: Omega-3 Ethyl Esters 2 g

  • No intervention
    Standard of Care

    Patients will not receive any study drug.

Interventions

  • DrugOmega-3 Ethyl Esters 4 g

    4 grams = 4 capsules, once daily

    Also known as: Omega-3 ethyl esters, Lovaza

  • DrugOmega-3 Ethyl Esters 2 g

    2 grams = 2 capsules, once daily

    Also known as: Lovaza, Omega-3 ethyl esters

06

What researchers measure

Primary outcomes

  1. Presence of Postoperative Delirium

    Number of patients that experienced postoperative delirium during the study.

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

Secondary outcomes

  1. Postoperative Delirium Symptoms

    Presence of any postoperative delirium symptoms during patient's hospital stay.

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

  2. Length of Stay

    Number of days patient stayed in hospital from the time of admission to discharge.

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

  3. Type of Anesthesia Used

    Number of patients administered anesthesia using mainly propofol or sevoflurane.

    Time frame: During surgery, up to 24 hours

  4. Amount of Pain Medication Given Postoperatively

    Average morphine milligram equivalents given to patients postoperatively until their discharge from the hospital.

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

07

Study locations

1 site
  • University Hospital
    Columbia, Missouri 65212, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 3, 2025
  • Informed consent form · Jul 9, 2025

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06434948
Lead sponsor
University of Missouri-Columbia
Responsible party
Quinn Johnson (Department Chair of Anesthesiology and Perioperative Medicine, University of Missouri-Columbia) — Principal investigator
First posted
May 30, 2024
Start date
Mar 3, 2026
Primary completion
Apr 29, 2026
Completion
Apr 29, 2026
Last update
May 11, 2026

Study contacts

Quinn Johnson, MD
principal investigator · University of Missouri-Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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