Oxepa for Mechanical Ventilation Complications

(ANUS1305 Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Grace Hospital, Cleveland, Ohio

Must not be taking: Immunosuppressants

Disqualifiers: Pulmonary fibrosis, Terminal illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

This trial tests a special tube feeding formula rich in certain nutrients and antioxidants for patients on mechanical ventilation. The goal is to help these patients recover faster, reduce their time on the ventilator, and lower their risk of complications.

Research Team

Basma Ricaurte, MD

Principal Investigator

Grace Hospital

Eligibility Criteria

This trial is for adults over 18 with respiratory failure who are on mechanical ventilation and have been unable to wean off. They must be diagnosed with ARDS, showing bilateral infiltrates in the lungs. It's not for those with very low WBC counts, HIV, using immunosuppressants, pregnant women, severe head trauma or coma patients, active bleeding disorders, liver failure, terminal illnesses expected to live less than 28 days, on hemodialysis or severe heart failure.

Exclusion Criteria

I have had a stroke.

My heart's pumping ability is significantly reduced.

I have a history of pulmonary fibrosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive enteral feeding high in EPA, GLA, and antioxidants or a comparator product

8 weeks

Weekly monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Jevity 1.5
• Oxepa

Trial Overview The study tests if Oxepa (high in EPA/GLA/antioxidants) versus Jevity 1.5 (isotonic high fiber nutrition) affects the number of days on mechanical ventilation and overall survival rates in LTAC patients. The goal is to see if Oxepa can help reduce time spent on ventilators and improve outcomes compared to standard enteral feeding.

Participant Groups

Group I: Oxepa Experimental Treatment 1 Intervention

Other: Therapeutic nutrition with EPA, GLA and antioxidants.

Group II: Jevity 1.5 Active Control 1 Intervention

Other: Jevity 1.5 Complete Balanced Nutrition with Fiber .

Who Is Running the Clinical Trial?

Grace Hospital, Cleveland, Ohio

Lead Sponsor

Trials

1

Recruited

40+

Abbott Nutrition

Industry Sponsor

Trials

173

Recruited

33,700+

Robert B. Ford

Abbott Nutrition

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Melissa Brotz

Abbott Nutrition

Chief Marketing Officer

Bachelor's degree in Journalism from Northwestern University