Frontlight ResearchEarly access
TerminatedPhase 2
The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery
Key facts
- Who runs it
- University of Missouri-Columbia
- Where
- Columbia, United StatesSee the site
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 1 person enrolled
- Started
- 3 Mar 2026
- Ended
- 29 Apr 2026
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Omega-3 Ethyl Esters 4 g
- Omega-3 Ethyl Esters 2 g
- Record updated
- 11 May 2026
- Why it stopped
- Unable to find a sufficient number of suitable study patients.
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Age ≥ 65 years
- American Society of Anesthesiologists (ASA) Class Physical Status I-IV
Who cannot take part
- Inability to take study drug due to intubation or other reason
- 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
- Known hypersensitivity (e.g. anaphylactic reaction) to omega-3 ethyl esters or any of its components
- Allergy to fish or shellfish
- 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
- 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
- Inability to obtain written informed consent
- Delirium present at screening
- History or diagnosis of thyroid problems such as hyperthyroidism or hypothyroidism
Where in United States
- University HospitalColumbia, United States
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Omega-3 Ethyl Esters 4 gTreatment being tested
Patients will be given 4 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.
- Omega-3 Ethyl Esters 2 gTreatment being tested
Patients will be given 2 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.
- Standard of CareNo study treatment, for comparison
Patients will not receive any study drug.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery: a Prospective, Randomized, Controlled Trial
- Record updated
- 11 May 2026