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

Phase 2TerminatedNCT06434948

University of Missouri-Columbia1 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Postoperative Delirium

Interventions

Omega-3 Ethyl Esters 4 gDRUG

4 grams = 4 capsules, once daily

Omega-3 Ethyl Esters 2 gDRUG

2 grams = 2 capsules, once daily

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital

Columbia, Missouri, United States

Outcomes

Primary Outcomes

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

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.

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.

Type of Anesthesia Used

Number of patients administered anesthesia using mainly propofol or sevoflurane.

Time frame: During surgery, up to 24 hours

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.

Data from ClinicalTrials.gov

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