Postoperative DeliriumPhase 2NCT06434948
The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery
A Phase 2 study testing Omega-3 Ethyl Esters 4 g and Omega-3 Ethyl Esters 2 g in people with Postoperative Delirium, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Omega-3 Ethyl Esters 4 g and Omega-3 Ethyl Esters 2 g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2026to 29 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- American Society of Anesthesiologists (ASA) Class Physical Status I-IV
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery: a Prospective, Randomized, Controlled Trial
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.
Read the 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
- Postoperative Delirium
- Being tested
- Omega-3 Ethyl Esters 4 g, Omega-3 Ethyl Esters 2 g
- Keywords
- postoperative delirium, delirium, fish oil, omega 3, Lovaza, cardiac bypass, omega 3 ethyl esters
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Ethyl Esters 4 gDrug
Also called Omega-3 ethyl esters, Lovaza
4 grams = 4 capsules, once daily
Omega-3 Ethyl Esters 2 gDrug
Also called Lovaza, Omega-3 ethyl esters
2 grams = 2 capsules, once daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Omega-3 Ethyl Esters 4 g |
| 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. Receives: Drug: Omega-3 Ethyl Esters 2 g |
| Standard of Care | No intervention | Patients will not receive any study drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Postoperative Delirium
Number of patients that experienced postoperative delirium during the study.
Measured: From the date of surgery until the patient is discharged, up to 30 days.
Secondary outcomes (4)
Postoperative Delirium Symptoms
Presence of any postoperative delirium symptoms during patient's hospital stay.
Measured: From the date of surgery until the patient is discharged, up to 30 days.
Length of Stay
Number of days patient stayed in hospital from the time of admission to discharge.
Measured: 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.
Measured: 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.
Measured: From the date of surgery until the patient is discharged, up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start3 Mar 2026
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Why it stopped: Unable to find a sufficient number of suitable study patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quinn Johnson, University of Missouri-Columbia
- Investigators
- Quinn Johnson, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434948
- Sponsor's protocol ID
- 2099184
- Status last verified
- Apr 2026
- First submitted
- 9 May 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery: a Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06434948
- Acronym / sponsor ID
- 2099184
- Conditions
- Postoperative Delirium
- Keywords
- postoperative delirium, delirium, fish oil, omega 3, Lovaza, cardiac bypass, omega 3 ethyl esters
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to find a sufficient number of suitable study patients.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Ethyl Esters 4 g | Experimental | Drug: Omega-3 Ethyl Esters 4 gPatients will be given 4 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively. |
| Omega-3 Ethyl Esters 2 g | Experimental | Drug: Omega-3 Ethyl Esters 2 gPatients will be given 2 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively. |
| Standard of Care | No intervention | –Patients will not receive any study drug. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age ≥ 65 years
- American Society of Anesthesiologists (ASA) Class Physical Status I-IV
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Ethyl Esters 4 gAlso: Omega-3 ethyl esters, Lovaza4 grams = 4 capsules, once daily | Drug | Omega-3 Ethyl Esters 4 g |
| Omega-3 Ethyl Esters 2 gAlso: Lovaza, Omega-3 ethyl esters2 grams = 2 capsules, once daily | Drug | Omega-3 Ethyl Esters 2 g |
Primary outcome
Presence of Postoperative Delirium
Time frame: From the date of surgery until the patient is discharged, up to 30 days.
Number of patients that experienced postoperative delirium during the study.
4 secondary outcomes
Postoperative Delirium Symptoms
Time frame: From the date of surgery until the patient is discharged, up to 30 days.
Length of Stay
Time frame: From the date of surgery until the patient is discharged, up to 30 days.
Type of Anesthesia Used
Time frame: During surgery, up to 24 hours
Amount of Pain Medication Given Postoperatively
Time frame: From the date of surgery until the patient is discharged, up to 30 days.
Results and safety
The study was stopped early (reason given: Unable to find a sufficient number of suitable study patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quinn Johnson, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 Ethyl Esters 4 g and Omega-3 Ethyl Esters 2 g in people with Postoperative Delirium, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to find a sufficient number of suitable study patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Postoperative Delirium (time frame: From the date of surgery until the patient is discharged, up to 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.