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NCT06434948 | NOT YET RECRUITING | Postoperative Delirium

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

University of Missouri-Columbia

Information provided by (Responsible Party):

Quinn Johnson

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.

Condition or disease

Postoperative Delirium

Intervention/treatment

Omega-3 Ethyl Esters 4 g

Omega-3 Ethyl Esters 2 g

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 90 participants
Masking : NONE
Masking Description : This study will not be blinded as there is no suitable placebo for omega-3 ethyl esters available at this time.
Primary Purpose : PREVENTION
Official Title : The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery: a Prospective, Randomized, Controlled Trial
Actual Study Start Date : 2025-08
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2027-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery

Location Details

NCT06434948

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Locations

Not yet recruiting

United States, Missouri

University Hospital

Columbia, Missouri, United States, 65212