Clinical trial NCT06434948: The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery
Official title: The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery: a Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Postoperative Delirium
Keywords: postoperative delirium
delirium
fish oil
omega 3
Lovaza
cardiac bypass
omega 3 ethyl esters
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: 4 grams of Omega-3 Ethyl Esters Arm 2: 2 grams of Omega-3 Ethyl Esters Arm 3: Standard of care
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of Postoperative Delirium
timeFrame: From the date of surgery until the patient is discharged, up to 30 days.
Secondary outcomes:
measure: Postoperative Delirium Symptoms
timeFrame: From the date of surgery until the patient is discharged, up to 30 days.
measure: Length of Stay
timeFrame: From the date of surgery until the patient is discharged, up to 30 days.
measure: Type of Anesthesia Used
timeFrame: During surgery, up to 24 hours
measure: Amount of Pain Medication Given Postoperatively
timeFrame: From the date of surgery until the patient is discharged, up to 30 days.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University Hospital
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Quinn Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: