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

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · May 29, 2024

Keywords

ClinConnect Summary

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.

Gender

ALL

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.

Trial Officials