## Protocol Section
### Identification Module
**NCT ID:** NCT06434948

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

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

#### Organization Study ID Info
**ID:** 2099184
#### Organization
**Class:** OTHER
**Full Name:** University of Missouri-Columbia
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Missouri-Columbia

#### Responsible Party

**Investigator Affiliation:** University of Missouri-Columbia

**Investigator Full Name:** Quinn Johnson

**Investigator Title:** Department Chair of Anesthesiology and Perioperative Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Postoperative Delirium

**Keywords:**

- postoperative delirium

- delirium

- fish oil

- omega 3

- Lovaza

- cardiac bypass

- omega 3 ethyl esters

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**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

##### Masking Info

**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

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will be given 4 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.

**Intervention Names:**

- Drug: Omega-3 Ethyl Esters 4 g

**Label:** Omega-3 Ethyl Esters 4 g

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients will be given 2 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.

**Intervention Names:**

- Drug: Omega-3 Ethyl Esters 2 g

**Label:** Omega-3 Ethyl Esters 2 g

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Patients will not receive any study drug.

**Label:** Standard of Care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Omega-3 Ethyl Esters 4 g

**Description:** 4 grams = 4 capsules, once daily

**Name:** Omega-3 Ethyl Esters 4 g

**Other Names:**

- Omega-3 ethyl esters

- Lovaza

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Omega-3 Ethyl Esters 2 g

**Description:** 2 grams = 2 capsules, once daily

**Name:** Omega-3 Ethyl Esters 2 g

**Other Names:**

- Lovaza

- Omega-3 ethyl esters

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Number of patients that experienced postoperative delirium during the study.

**Measure:** Presence of Postoperative Delirium

**Time Frame:** From the date of surgery until the patient is discharged, up to 30 days.

#### Secondary Outcomes

**Description:** Concentrations of cytokines in blood collected before patient is put on cardiac bypass, immediately after bypass, and 1, 2, and 3 days postoperative.

**Measure:** Cytokine Concentrations

**Time Frame:** 0, 1, 2, 3 days postoperatively

**Description:** 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.

**Measure:** Polyunsaturated Fatty Acid Concentrations

**Time Frame:** 0, 1, 2, 3 days postoperatively

**Description:** Presence of any postoperative delirium symptoms during patient's hospital stay.

**Measure:** Postoperative Delirium Symptoms

**Time Frame:** From the date of surgery until the patient is discharged, up to 30 days.

**Description:** Number of days patient stayed in hospital from the time of admission to discharge.

**Measure:** Length of Stay

**Time Frame:** From the date of surgery until the patient is discharged, up to 30 days.

**Description:** Number of patients administered anesthesia using mainly propofol or sevoflurane.

**Measure:** Type of Anesthesia Used

**Time Frame:** Day of surgery

**Description:** Average morphine milligram equivalents given to patients postoperatively until their discharge from the hospital.

**Measure:** Amount of Pain Medication Given Postoperatively

**Time Frame:** From the date of surgery until the patient is discharged, up to 30 days.

### Eligibility Module

**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.

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** aburger@umsystem.edu

**Name:** Antoinette Burger, PhD

**Phone:** 5738843740

**Role:** CONTACT

**Contact 2:**

**Email:** pasbxw@umsystem.edu

**Name:** Paige Spencer, BS

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** University of Missouri-Columbia

**Name:** Quinn Johnson, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003221

- Term: Confusion

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6894

- Name: Delirium

- Relevance: HIGH

- As Found: Delirium

- ID: M772

- Name: Emergence Delirium

- Relevance: HIGH

- As Found: Postoperative Delirium

- ID: M6446

- Name: Confusion

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003693

- Term: Delirium

- ID: D000071257

- Term: Emergence Delirium

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T415

- Name: Omega 3 Fatty Acid

- Relevance: HIGH

- As Found: Unacceptable

### Misc Info Module

- Version Holder: 2024-05-31
