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Enteral Nutrition
Oxepa for Mechanical Ventilation Complications (ANUS1305 Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days from start of enteral feeding
Awards & highlights
ANUS1305 Trial Summary
This trial suggests that feeding patients in the critical care setting an enteral product high in EPA, GLA, and antioxidants can improve weaning rates and decrease mortality rates.
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.Check my eligibility
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.See study design
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.
ANUS1305 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18, on a ventilator due to ARDS, and cannot breathe on my own.
ANUS1305 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days from start of enteral feeding
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days from start of enteral feeding
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of days on mechanical ventilation
Side effects data
From 2013 Phase 2 trial • 28 Patients • NCT0098398367%
Diarrhea
50%
Constipation
33%
Dyspnea (shortness of breath)
33%
Dyspnea-Shortness of Breath
33%
Pain-Abdomen/Stomach
33%
Oral/Perioral Infection
17%
Fatigue
17%
Depression
17%
Head Cold/Sinusitis
17%
Infection-Bronchus
17%
Dysphagia
17%
Anorexia
17%
Drooling
17%
Cough/Congestion
17%
Weakness-Trunk
17%
Abrasion
17%
Detached feeding tube/Replacement of feeding tube
17%
Cellulitis
17%
Insomnia
17%
Upset Stomach
17%
Sore Throat
17%
Fall
17%
Weight Loss
17%
Bloating/Flatulence
17%
Heartburn
17%
Nausea
17%
Infection-Urinary Tract
17%
Pain-Abdomen
17%
Dry Mouth
17%
Borborygmi
17%
Extremity Weakness
17%
Neck Muscle Soreness
17%
Hemorrhoids
17%
Infection-Lung (Pneumonia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
High Fat/High Calorie
High Calorie/High Carbohydrate
Control
ANUS1305 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 .
Find a Location
Who is running the clinical trial?
Grace Hospital, Cleveland, OhioLead Sponsor
Abbott NutritionIndustry Sponsor
168 Previous Clinical Trials
33,464 Total Patients Enrolled
Basma Ricaurte, MDPrincipal InvestigatorGrace Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stroke.My heart's pumping ability is significantly reduced.I am over 18, on a ventilator due to ARDS, and cannot breathe on my own.I have a history of pulmonary fibrosis.I have a terminal illness or cancer.I have a low white blood cell count, am HIV positive, or take drugs that weaken my immune system.I am on hemodialysis.I had a severe head injury with a very low consciousness level.You are not expected to live more than 28 days.I do not have active bleeding or a bleeding disorder like DIC, sickle cell anemia, or hemophilia.My liver is not working properly.
Research Study Groups:
This trial has the following groups:- Group 1: Oxepa
- Group 2: Jevity 1.5
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies left in this experiment for participants?
"According to clinicaltrials.gov, this medical trial is no longer actively recruiting patients; the initial post was created on January 1st 2014 and last edited August 1st of that year. However, other trials remain available for patient enrollment with a total of 224 studies currently seeking participants."
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