Oxepa for Mechanical Ventilation Complications
(ANUS1305 Trial)
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.12345
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.24678
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive enteral feeding high in EPA, GLA, and antioxidants or a comparator product
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
Other: Therapeutic nutrition with EPA, GLA and antioxidants.
Other: Jevity 1.5 Complete Balanced Nutrition with Fiber .
Find a Clinic Near You
Who Is Running the Clinical Trial?
Grace Hospital, Cleveland, Ohio
Lead Sponsor
Abbott Nutrition
Industry Sponsor
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
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.
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_PositionEnteral Nutrition in Patients Receiving Mechanical ...
Background: Patients treated with mechanical ventilation in the prone position (PP) could have an increased risk for feeding intolerance.
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.
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%), ...
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.
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 ...
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 ...
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.