What side effects are associated with this type of intervention?

Enteral nutrition high in eicosapentaenoic acid (EPA), gamma-linolenic acid (GLA), and antioxidants is used to manage complications in mechanically ventilated patients by reducing inflammation and supporting immune function. Known side effects of such nutritional interventions can include gastrointestinal disturbances such as diarrhea, nausea, and bloating. Additionally, there is a potential risk of over-supplementation leading to imbalances in fatty acids and antioxidants, which could potentially cause oxidative stress or interfere with other metabolic processes. Further controlled studies are needed to confirm these findings and fully understand the safety profile.

What prior FDA approvals exist?

There are no specific FDA-approved treatments directly targeting mechanical ventilation complications with the same anti-inflammatory and immune-modulating properties as enteral nutrition high in EPA, GLA, and antioxidants. However, supportive care strategies, including optimized enteral nutrition, are commonly used to manage these complications. Enteral nutrition formulations high in eicosapentaenoic acid (EPA), gamma-linolenic acid (GLA), and antioxidants have shown promise in reducing inflammation and improving outcomes in patients with acute respiratory distress syndrome (ARDS), a common complication of mechanical ventilation. Further studies are needed to confirm these findings and potentially lead to FDA approval.

What other types of research exist?

Promising novel alternatives for patients on mechanical ventilation include inhaled nitric oxide and inhaled prostacyclin, which have shown benefits in improving gas exchange and reducing pulmonary hypertension in ARDS patients. Additionally, antioxidant therapies such as vitamin E and omega-3 supplementation have demonstrated potential in reducing oxidative stress and improving outcomes in critically ill patients. These alternatives may offer complementary benefits to traditional enteral nutrition approaches.

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Enteral Nutrition

Oxepa for Mechanical Ventilation Complications (ANUS1305 Trial)

Q: What is the mechanism of action of this treatment?

Treatments for mechanical ventilation complications, such as enteral nutrition high in EPA, GLA, and antioxidants, work primarily through anti-inflammatory and immune-modulating mechanisms. Omega-3 fatty acids like EPA and GLA help reduce inflammation by modulating the immune response and decreasing pro-inflammatory cytokine production. Antioxidants mitigate oxidative stress by neutralizing free radicals, thereby reducing cellular damage. These mechanisms are crucial for improving patient outcomes, as they can shorten the duration of mechanical ventilation, lower mortality rates, and minimize the risk of organ failure.

N/A

Waitlist Available

Led By Basma Ricaurte, MD

Research Sponsored by Grace Hospital, Cleveland, Ohio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

>18 years old with Respiratory failure on mechanical ventilation with failure to wean Diagnosis of ARDS (Acute respiratory Distress Syndrome) Bilateral infiltrates

Be older than 18 years old

Must not have

Hemorrhagic or ischemic stroke

Heart Failure with EF(Ejection Fraction) <35%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here for Oxepa or Jevity 1.5 enteral feedings; generally such nutritional interventions might cause gastrointestinal discomforts like bloating or diarrhea and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18, on a ventilator due to ARDS, and cannot breathe on my own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a stroke.

Select...

My heart's pumping ability is significantly reduced.

Select...

I have a history of pulmonary fibrosis.

Select...

I have a terminal illness or cancer.

Select...

I have a low white blood cell count, am HIV positive, or take drugs that weaken my immune system.

Select...

I am on hemodialysis.

Select...

I had a severe head injury with a very low consciousness level.

Select...

I do not have active bleeding or a bleeding disorder like DIC, sickle cell anemia, or hemophilia.

Select...

My liver is not working properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2013 Phase 2 trial • 28 Patients • NCT00983983

50%

Aspiration

50%

Diarrhea

50%

Bloating/Flatulence

33%

Fatigue

33%

Infection-Urinary Tract

33%

Infection-Lung (Pneumonia)

17%

Dyspnea (shortness of breath)

17%

Infection-Lung

17%

Atrial Fibrillation

17%

Elevated Troponin

17%

Thrombocytopenia

17%

Heartburn

17%

Nausea

17%

Pain-Abdomen

17%

Dyspnea-Shortness of Breath

17%

Pleural Effusion (non-malignant)

17%

Head Cold/Sinusitis

17%

Blocked Foley Catheter

17%

"Right arm and leg puffiness"

17%

Weight Gain

17%

Esophagitis/Esophageal Spasm

17%

Burping

17%

Increased Bowel Movements

17%

Abdominal Fullness

17%

C. difficile Infection

17%

Pain-Abdomen/Stomach

17%

Hypoxia

17%

Stomach Pain

17%

Depression

17%

Protein-Calorie Malnutrition

100%

80%

60%

40%

20%

Study treatment Arm

Control

High Fat/High Calorie

High Calorie/High Carbohydrate

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OxepaExperimental Treatment1 Intervention

Other: Therapeutic nutrition with EPA, GLA and antioxidants.

Group II: Jevity 1.5Active Control1 Intervention

Other: Jevity 1.5 Complete Balanced Nutrition with Fiber .

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Treatments for mechanical ventilation complications, such as enteral nutrition high in EPA, GLA, and antioxidants, work primarily through anti-inflammatory and immune-modulating mechanisms. Omega-3 fatty acids like EPA and GLA help reduce inflammation by modulating the immune response and decreasing pro-inflammatory cytokine production. Antioxidants mitigate oxidative stress by neutralizing free radicals, thereby reducing cellular damage. These mechanisms are crucial for improving patient outcomes, as they can shorten the duration of mechanical ventilation, lower mortality rates, and minimize the risk of organ failure.

[Nutrition and acute respiratory failure].Update on antioxidant micronutrients in the critically ill.Immunonutrients in critically ill patients: an analysis of the most recent literature.