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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

This study will not be blinded as there is no suitable placebo for omega-3 ethyl esters available at this time.

Study Groups

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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.

Group Type EXPERIMENTAL

Omega-3 Ethyl Esters 4 g

Intervention Type DRUG

4 grams = 4 capsules, once daily

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.

Group Type EXPERIMENTAL

Omega-3 Ethyl Esters 2 g

Intervention Type DRUG

2 grams = 2 capsules, once daily

Standard of Care

Patients will not receive any study drug.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Omega-3 Ethyl Esters 4 g

4 grams = 4 capsules, once daily

Intervention Type DRUG

Omega-3 Ethyl Esters 2 g

2 grams = 2 capsules, once daily

Intervention Type DRUG

Other Intervention Names

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Omega-3 ethyl esters Lovaza Lovaza Omega-3 ethyl esters

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No