Acute Lung InjuryANUS1305NCT02208700
Efficacy of Oxepa Enteral Feeding in LTAC (Long Term Acute Care Hospital) Patients on Chronic Ventilation- a Pilot Study
A study testing Oxepa and Jevity 1.5 in people with Acute Lung Injury and Mechanical Ventilation Complication, run by Grace Hospital, Cleveland, Ohio at 1 site in United States.
Trial summary
Patients with mechanical ventilation have shown improved weaning rates when enteral tube feeding high in EPA, GLA and antioxidants were fed to patients in the critical care setting. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Lung Injury, Mechanical Ventilation Complication, Dietary Modification
- What is being tested?
- Oxepa and Jevity 1.5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old with Respiratory failure on mechanical ventilation with failure to wean Diagnosis of ARDS (Acute respiratory Distress Syndrome) Bilateral infiltrates -
Who cannot join
- History Of pulmonary fibrosis, Terminal illness/ malignancies, <28 day life expectancy, Hemodialysis, Active bleeding or bleeding disorder: DIC ( Disseminated intravascular Coagulation), Sickle Cell Anemia, Hemophilia Hemorrhagic or ischemic stroke, Liver failure, Head trauma with Glasgow coma scale score of <5, Immunosuppression: WBC(White Blood Cell Count) <5000, HIV positive, use of immunosuppressant drugs, Pregnancy, and Heart Failure with EF(Ejection Fraction) <35%
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Grace Hospital
Cleveland, Ohio, 44111
Carol Gorbach-Melchioris, MEd, RDNLD, 216-476-2704, cgorbach-melchhioris@gracehospital.org
Basma Ricaurte, MD
About this study
Official title: Efficacy of the Use of Enteral Feeding High in EPA,GLA and Antioxidants in LTAC Patients on Chronic Ventilation- a Pilot Study
Patients with mechanical ventilation have shown improved weaning rates when enteral tube feeding high in EPA, GLA and antioxidants were fed to patients in the critical care setting.
LTAC Patients on chronic mechanical ventilation will have decreased days an mechanical ventilation, decreased mortality rates and decreased organ failure when fed an enteral product high in EPA, GLA and antioxidants compared to an isotonic high fiber enteral nutrition product.
- Being tested
- Oxepa, Jevity 1.5
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxepaOther
Therapeutic nutrition with EPA, GLA< and antioxidants
Jevity 1.5Other
Complete balanced nutrition with a unique fiber blend
| Study group | Role | What they receive |
|---|---|---|
| Oxepa | Experimental | Other: Therapeutic nutrition with EPA, GLA and antioxidants. Receives: Other: Oxepa |
| Jevity 1.5 | Active comparator | Other: Jevity 1.5 Complete Balanced Nutrition with Fiber . Receives: Other: Jevity 1.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of days on mechanical ventilation
Measured: 14 days from start of enteral feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grace Hospital, Cleveland, Ohio
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition
- Responsible party
- Sponsor
- Investigators
- Basma Ricaurte, MD, Principal investigator, Grace Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208700
- Sponsor's protocol ID
- 1141459
- Acronym
- ANUS1305
- Status last verified
- Aug 2014
- First submitted
- 1 Aug 2014
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Use of Enteral Feeding High in EPA,GLA and Antioxidants in LTAC Patients on Chronic Ventilation- a Pilot Study
- ClinicalTrials.gov ID
- NCT02208700
- Acronym / sponsor ID
- ANUS1305 / 1141459
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Grace Hospital, Cleveland, OhioUniversity, hospital or other
- Collaborators
- Abbott Nutrition
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (estimated)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with mechanical ventilation have shown improved weaning rates when enteral tube feeding high in EPA, GLA and antioxidants were fed to patients in the critical care setting.
LTAC Patients on chronic mechanical ventilation will have decreased days an mechanical ventilation, decreased mortality rates and decreased organ failure when fed an enteral product high in EPA, GLA and antioxidants compared to an isotonic high fiber enteral nutrition product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxepa | Experimental | Other: OxepaOther: Therapeutic nutrition with EPA, GLA and antioxidants. |
| Jevity 1.5 | Active comparator | Other: Jevity 1.5Other: Jevity 1.5 Complete Balanced Nutrition with Fiber . |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 years old with Respiratory failure on mechanical ventilation with failure to wean Diagnosis of ARDS (Acute respiratory Distress Syndrome) Bilateral infiltrates -
Key exclusion criteria (2 listed)
- History Of pulmonary fibrosis, Terminal illness/ malignancies, <28 day life expectancy, Hemodialysis, Active bleeding or bleeding disorder: DIC ( Disseminated intravascular Coagulation), Sickle Cell Anemia, Hemophilia Hemorrhagic or ischemic stroke, Liver failure, Head trauma with Glasgow coma scale score of <5, Immunosuppression: WBC(White Blood Cell Count) <5000, HIV positive, use of immunosuppressant drugs, Pregnancy, and Heart Failure with EF(Ejection Fraction) <35%
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxepaTherapeutic nutrition with EPA, GLA< and antioxidants | Other | Oxepa |
| Jevity 1.5Complete balanced nutrition with a unique fiber blend | Other | Jevity 1.5 |
Primary outcome
Length of days on mechanical ventilation
Time frame: 14 days from start of enteral feeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basma Ricaurte, MD principal investigator
Grace Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxepa and Jevity 1.5 in people with Acute Lung Injury and Mechanical Ventilation Complication, run by Grace Hospital, Cleveland, Ohio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of days on mechanical ventilation (time frame: 14 days from start of enteral feeding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.