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

University of Missouri (MU)

Status and phase: Invitation-only; Phase 2

Conditions: Postoperative Delirium

Treatments: Drug: Omega-3 Ethyl Esters 2 g; Drug: Omega-3 Ethyl Esters 4 g

Study type: Interventional

Funder types: Other

Identifiers

NCT06434948

2099184

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Omega-3 Ethyl Esters 4 g

Experimental group

Description:

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

Treatment:

Drug: Omega-3 Ethyl Esters 4 g

Omega-3 Ethyl Esters 2 g

Experimental group

Description:

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

Treatment:

Drug: Omega-3 Ethyl Esters 2 g

Standard of Care

No Intervention group

Description:

Patients will not receive any study drug.