Omega-3 for Delirium

Overseen By Antoinette Burger, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Missouri-Columbia

Must not be taking: Anticoagulants, Omega-3, Omega-6, others

Disqualifiers: Diabetes, Neurodegenerative, Bleeding, Metabolic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether omega-3 fatty acids (specifically Omega-3 Ethyl Esters) can reduce confusion and memory issues, known as delirium, after heart surgery. Participants will take either 2 grams or 4 grams of omega-3 before and after surgery, or receive standard care without omega-3. The trial targets individuals preparing for heart bypass surgery who have not experienced delirium before and are not taking specific medications like blood thinners or fish oil supplements. Those who have had heart surgery and are concerned about postoperative confusion, and are not currently on certain medications, might find this trial suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you stop taking any omega-3, omega-6, vitamin E, or fish oil supplements, as well as any anticoagulant drugs like warfarin, apixaban, dabigatran, edoxaban, or rivaroxaban. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that omega-3 ethyl esters are generally safe for use. They often lower high levels of triglycerides in the blood, making them considered safe for this purpose. However, some individuals might experience mild side effects such as an upset stomach, a fishy taste, or burping.

In this specific study, previous participants did not experience any serious reactions to omega-3 ethyl esters. It is important to note that individuals allergic to fish or omega-3 ethyl esters should avoid this treatment.

This study is in an early phase, so while some safety information is available, the treatment is still being tested for this specific use. Overall, omega-3 ethyl esters have a good safety record for other uses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for delirium?

Researchers are excited about Omega-3 Ethyl Esters for delirium because these treatments use omega-3 fatty acids, which are natural compounds often found in fish oil, and they might have a new way of reducing inflammation in the brain. Unlike traditional treatments for delirium that typically involve antipsychotics or sedatives, which can have significant side effects, Omega-3 Ethyl Esters offer a potentially safer and more natural approach. Moreover, this study explores different dosages — 2 grams and 4 grams — to assess the most effective amount, providing valuable insights into optimizing treatment. This natural approach is particularly appealing because it may enhance recovery without the drawbacks of conventional medications.

What evidence suggests that omega-3 ethyl esters might be an effective treatment for postoperative delirium?

Research has shown that omega-3 fatty acids can decrease the number of days patients experience delirium in the ICU. One study found that omega-3s protect the brain by reducing damage and swelling after surgery, which might help prevent delirium. Omega-3s have also improved symptoms in some mental health conditions. In this trial, participants will receive either 2 grams or 4 grams of omega-3 ethyl esters, or standard care without the study drug, to evaluate if omega-3 ethyl esters help prevent delirium after heart surgeries by reducing brain inflammation and protecting brain function. ^{1 2 5 6 7}

Who Is on the Research Team?

Quinn Johnson, MD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 or older who are undergoing major cardiac surgery and have a physical status classified as I-IV by the American Society of Anesthesiologists. It's not specified, but typically people with certain health conditions that could interfere with the study may be excluded.

Inclusion Criteria

My health is classified between ASA I and IV.

I am 65 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive omega-3 ethyl esters orally before surgery

1 week

Postoperative Treatment

Participants continue to receive omega-3 ethyl esters for 3 days postoperatively

3 days

Follow-up

Participants are monitored for postoperative delirium and other outcomes until discharge

Up to 30 days

What Are the Treatments Tested in This Trial?

Interventions

• Omega-3 Ethyl Esters

Trial Overview The study is testing if omega-3 fatty acids at doses of either 4 grams or 2 grams can reduce postoperative delirium when given before and after cardiac bypass surgeries to elderly patients.

How Is the Trial Designed?

Group I: Omega-3 Ethyl Esters 4 g Experimental Treatment 1 Intervention

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

Group II: Omega-3 Ethyl Esters 2 g Experimental Treatment 1 Intervention

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

Group III: Standard of Care Active Control 1 Intervention

Patients will not receive any study drug.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06434948?term=AREA%5BBasicSearch%5D(OMEGA-3-ACID%20ETHYL%20ESTER)&rank=8

The Effect of Omega 3 Supplementation on Postoperative ... Delirium present at screening. Known hypersensitivity (e.g. anaphylactic reaction) to omega-3 ethyl esters or any of its components; Allergy to fish or ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7003546/

Role of omega-3 fatty acids in the prevention of delirium ... The results of recent research showed that omega-3 is effective in reducing the delirium days in patients whom admitted to the ICU.

3. withpower.com withpower.com/trial/phase-2-delirium-5-2024-77afe

Omega-3 for Delirium · Info for Participants Research shows that omega-3 fatty acids, like those in Omega-3 Ethyl Esters, have been helpful in reducing symptoms of mental health conditions such as ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35778276/

Protective effects of omega-3 fatty acids in a blood-brain ... In vivo studies confirmed that omega-3 fatty acid treatment inhibited surgery-induced BBB impairment, microglial activation, and delirium-like behaviour.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622109867

Fish Oil Supplementation Does Not Affect Cognitive ... The effects of omega-3 fatty acids monotherapy in Alzheimer's disease and mild cognitive impairment: a preliminary randomized double-blind placebo ...

6. go.drugbank.com go.drugbank.com/drugs/DB09539

Omega-3-acid ethyl esters Omega-3-acid ethyl esters reduce triglyceride production, increase fatty acid metabolism, inhibit the release of fatty acids, increase ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/omega-3-acid-ethyl-esters-oral-route/description/drg-20066973

Omega-3-acid ethyl esters (oral route) - Side effects & ... Omega-3-acid ethyl esters are used together with a proper diet to lower very high triglyceride (fat-like substance) levels in the blood.