Postoperative Delirium
Conditions
Keywords
postoperative delirium, delirium, fish oil, omega 3, Lovaza, cardiac bypass, omega 3 ethyl esters
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.
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.
Interventions
DRUGOmega-3 Ethyl Esters 4 g
4 grams = 4 capsules, once daily
DRUGOmega-3 Ethyl Esters 2 g
2 grams = 2 capsules, once daily
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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.
Intervention model description
Arm 1: 4 grams of Omega-3 Ethyl Esters Arm 2: 2 grams of Omega-3 Ethyl Esters Arm 3: Standard of care
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Postoperative Delirium | From the date of surgery until the patient is discharged, up to 30 days. | Number of patients that experienced postoperative delirium during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Delirium Symptoms | From the date of surgery until the patient is discharged, up to 30 days. | Presence of any postoperative delirium symptoms during patient's hospital stay. |
| Length of Stay | From the date of surgery until the patient is discharged, up to 30 days. | Number of days patient stayed in hospital from the time of admission to discharge. |
| Type of Anesthesia Used | During surgery, up to 24 hours | Number of patients administered anesthesia using mainly propofol or sevoflurane. |
| Amount of Pain Medication Given Postoperatively | From the date of surgery until the patient is discharged, up to 30 days. | Average morphine milligram equivalents given to patients postoperatively until their discharge from the hospital. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORQuinn Johnson, MD
University of Missouri-Columbia
Outcome results
None listed