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

Postoperative Delirium Clinical Trial

Official title:

The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery: a Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434948
• Other study ID #: 2099184
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University of Missouri-Columbia
• Contact: Antoinette Burger, PhD
• Phone: 5738843740
• Email: aburger[@]umsystem.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Intervention

Drug:
• Omega-3 Ethyl Esters 4 g
4 grams = 4 capsules, once daily
• Omega-3 Ethyl Esters 2 g
2 grams = 2 capsules, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Postoperative Delirium	Number of patients that experienced postoperative delirium during the study.	From the date of surgery until the patient is discharged, up to 30 days.
Secondary	Cytokine Concentrations	Concentrations of cytokines in blood collected before patient is put on cardiac bypass, immediately after bypass, and 1, 2, and 3 days postoperative.	0, 1, 2, 3 days postoperatively
Secondary	Polyunsaturated Fatty Acid Concentrations	Concentrations of polyunsaturated fatty acids in blood collected before patient is put on cardiac bypass, immediately after bypass, and 1, 2, and 3 days postoperative.	0, 1, 2, 3 days postoperatively
Secondary	Postoperative Delirium Symptoms	Presence of any postoperative delirium symptoms during patient's hospital stay.	From the date of surgery until the patient is discharged, up to 30 days.
Secondary	Length of Stay	Number of days patient stayed in hospital from the time of admission to discharge.	From the date of surgery until the patient is discharged, up to 30 days.
Secondary	Type of Anesthesia Used	Number of patients administered anesthesia using mainly propofol or sevoflurane.	Day of surgery
Secondary	Amount of Pain Medication Given Postoperatively	Average morphine milligram equivalents given to patients postoperatively until their discharge from the hospital.	From the date of surgery until the patient is discharged, up to 30 days.