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

This clinical trial is investigating whether taking omega-3 fatty acids can help reduce the risk of postoperative delirium in older patients who are undergoing major heart surgeries, like cardiac bypass. Postoperative delirium is a condition where patients experience confusion or changes in their mental state after surgery, which can occur more frequently in elderly patients. The study aims to determine if giving omega-3 supplements both before and after the surgery can make a difference in how often this happens.

To join the trial, participants need to be at least 65 years old and in varying degrees of health as classified by the American Society of Anesthesiologists. However, certain conditions would prevent someone from participating, such as having an allergy to omega-3 or fish, being unable to take the medication due to medical reasons, or having certain health issues like significant kidney or liver disease. If eligible, participants will be informed about the study and will take omega-3 supplements as part of their care during the surgical process. This trial is not yet recruiting, so more details will be provided as it gets underway.

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.