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Unable to find a sufficient number of suitable study patients.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 Ethyl Esters 4 g | Experimental | Patients will be given 4 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively. |
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| Omega-3 Ethyl Esters 2 g | Experimental | Patients will be given 2 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively. |
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| Standard of Care | No Intervention | Patients will not receive any study drug. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Ethyl Esters 4 g | Drug | 4 grams = 4 capsules, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Length of Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quinn Johnson, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Columbia | Missouri | 65212 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2025 | Apr 29, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2025 | Apr 29, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
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Arm 1: 4 grams of Omega-3 Ethyl Esters Arm 2: 2 grams of Omega-3 Ethyl Esters Arm 3: Standard of care
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This study will not be blinded as there is no suitable placebo for omega-3 ethyl esters available at this time.
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| Omega-3 Ethyl Esters 2 g | Drug | 2 grams = 2 capsules, once daily |
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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. |
| Type of Anesthesia Used | Number of patients administered anesthesia using mainly propofol or sevoflurane. | During surgery, up to 24 hours |
| 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. |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |