The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Ma… (NCT06434948) | Clinical Trial Compass
By InvitationPhase 2
The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery
United States90 participantsStarted 2026-03-03
Plain-language 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.
Who can participate
Age range65 Years
SexALL
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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.
What they're measuring
1
Presence of Postoperative Delirium
Timeframe: From the date of surgery until the patient is discharged, up to 30 days.