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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a special nutrition formula, Oxepa, can help patients on mechanical ventilation recover better than a standard nutrition product. The researchers aim to determine if Oxepa, rich in nutrients like EPA, GLA, and antioxidants, can reduce the time patients need mechanical breathing assistance, lower mortality rates, and decrease organ complications. Suitable candidates for this trial are individuals over 18 with respiratory failure, struggling to breathe independently, and diagnosed with ARDS (a severe lung condition). As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in nutritional support for critical care patients.

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.

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

Research has shown that Oxepa, a special nutrition formula rich in certain nutrients and antioxidants, is generally well-tolerated by patients. Some studies mention that, like any nutritional treatment, it can cause minor side effects such as stomach discomfort. However, Oxepa is not suitable for everyone. People with very low white blood cell counts, those with HIV, individuals taking medications that suppress the immune system, pregnant women, people with severe head injuries or in a coma, and those with active bleeding disorders should avoid it. Overall, Oxepa is considered safe for most patients without these conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard nutritional support for mechanical ventilation complications, which typically focuses on balanced nutrition with fiber, Oxepa is unique because it contains therapeutic nutrition with EPA (eicosapentaenoic acid), GLA (gamma-linolenic acid), and antioxidants. These components are believed to help reduce inflammation and support immune function, which are crucial for patients on mechanical ventilation. Researchers are excited about Oxepa because its specific blend of nutrients could potentially improve outcomes by addressing the inflammatory and oxidative stress aspects of critical illness in a way that standard nutritional formulas do not.

What evidence suggests that Oxepa might be an effective treatment for mechanical ventilation complications?

Research has shown that feeding patients through a tube with a special nutrition mix high in certain omega fatty acids and antioxidants can aid those on breathing machines. One study found that patients receiving this nutrition had better oxygen levels and could stop heart-supporting medication sooner. Another study suggested this approach may lower the risk of complications like lung infections from the ventilator. While it might not greatly improve lung function, the overall benefits, such as quicker recovery from certain treatments, are promising. In this trial, participants will receive either Oxepa, which contains these important nutrients, or Jevity 1.5 as a comparator. These findings suggest that Oxepa could improve the health of patients on mechanical ventilation. ^{2 4 6 7 8}

Who Is on the Research Team?

Basma Ricaurte, MD

Principal Investigator

Grace Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. withpower.com withpower.com/trial/phase-acute-lung-injury-2014-21531

Oxepa for Mechanical Ventilation Complications · Info ... This trial tests a special tube feeding formula rich in certain nutrients and antioxidants for patients on mechanical ventilation.

2. link.springer.com link.springer.com/article/10.1007/s00134-015-3646-z

a prospective, randomized, double-blind study Primary outcome measures included the level of oxygenation (PaO2/FiO2 ratio, PF ratio) on days 4 and 8, incidence of acute lung injury (ALI) and ...

3. researchgate.net researchgate.net/publication/266570232_Enteral_Nutrition_in_Patients_Receiving_Mechanical_Ventilation_in_a_Prone_Position

Enteral Nutrition in Patients Receiving Mechanical ... Background: Patients treated with mechanical ventilation in the prone position (PP) could have an increased risk for feeding intolerance.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0261561421001813

Enteral and supplemental parenteral nutrition enriched ... Enteral and supplemental PN both enriched with omega-3 PUFA did not improve lung function but allowed earlier weaning from catecholamine treatment and PN.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12309813/

Mechanical ventilation-associated complications and ... One-quarter (24.1%) of the patients experienced at least one AE. Ventilator-associated pneumonia (VAP) was the most common consequence (13%), ...

6. globalrx.com globalrx.com/articles?article=oxepa-therapeutic-nutrition-profile&product_id=79992

Clinical Profile of Oxepa Therapeutic Nutrition Oxepa is generally well-tolerated by patients. However, as with any nutritional therapy, potential side effects such as gastrointestinal discomfort may occur.

7. empr.com empr.com/drug/oxepa/

OXEPA Prescription & Dosage Information - MPR Sole-source tube-feeding for critically ill patients on mechanical ventilation. Oxepa Dosage and Administration Adults and Children Provides 355Cal/8oz (1500 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4443653/

Effect of enteral diet enriched with eicosapentaenoic acid ... This study showed that an enteral diet enriched with EPA, GLA, and antioxidants did not significantly improve duration of mechanical ventilation, total SOFA ...