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

NCT06434948 | Terminated Phase 2 FDA Drug

• 1 other identifier: 2099184
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Delirium

Keywords

postoperative delirium; delirium; fish oil; omega 3; Lovaza; cardiac bypass; omega 3 ethyl esters

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Postoperative Delirium Symptoms

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

• Length of Stay

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

• Type of Anesthesia Used

  During surgery, up to 24 hours

• Amount of Pain Medication Given Postoperatively

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

Study Arms (3)

Omega-3 Ethyl Esters 4 g

EXPERIMENTAL

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

Omega-3 Ethyl Esters 2 g

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Patients will not receive any study drug.

Interventions

Omega-3 Ethyl Esters 4 g DRUG

4 grams = 4 capsules, once daily

Also known as: Omega-3 ethyl esters, Lovaza

Omega-3 Ethyl Esters 4 g

Omega-3 Ethyl Esters 2 g DRUG

2 grams = 2 capsules, once daily

Also known as: Lovaza, Omega-3 ethyl esters

Omega-3 Ethyl Esters 2 g

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University Hospital

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Emergence Delirium; Delirium

Interventions

Omacor

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Quinn Johnson, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study will not be blinded as there is no suitable placebo for omega-3 ethyl esters available at this time.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair of Anesthesiology and Perioperative Medicine

Model Details: Arm 1: 4 grams of Omega-3 Ethyl Esters Arm 2: 2 grams of Omega-3 Ethyl Esters Arm 3: Standard of care

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 30, 2024
• Study Start: March 3, 2026
• Primary Completion: April 29, 2026
• Study Completion: April 29, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-04

Locations

US (1)