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

The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery: a Prospective, Randomized, Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Delirium
• Intervention / Treatment: Drug: Omega-3 Ethyl Esters 4 g; Drug: Omega-3 Ethyl Esters 2 g

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 4 grams = 4 capsules, once daily; Other Names: Lovaza; Omega-3 ethyl esters
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; 2 grams = 2 capsules, once daily; Other Names: Lovaza; Omega-3 ethyl esters
No Intervention: Standard of Care; Patients will not receive any study drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Postoperative Delirium	Number of patients that experienced postoperative delirium during the study.	From the date of surgery until the patient is discharged, up to 30 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Delirium Symptoms	Presence of any postoperative delirium symptoms during patient's hospital stay.	From the date of surgery until the patient is discharged, up to 30 days.
Length of Stay	Number of days patient stayed in hospital from the time of admission to discharge.	From the date of surgery until the patient is discharged, up to 30 days.
Amount of Pain Medication Given Postoperatively	Average morphine milligram equivalents given to patients postoperatively until their discharge from the hospital.	From the date of surgery until the patient is discharged, up to 30 days.
Type of Anesthesia Used	Number of patients administered anesthesia using mainly propofol or sevoflurane.	During surgery, up to 24 hours

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Quinn Johnson, MD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2026
• Primary Completion (Actual): April 29, 2026
• Study Completion (Actual): April 29, 2026

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: delirium; omega 3; postoperative delirium; cardiac bypass; Lovaza; fish oil; omega 3 ethyl esters
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Delirium; Omacor
• Other Study ID Numbers: 2099184

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes