Recruiting

Oxepa

Sponsor:

Grace Hospital, Cleveland, Ohio

Code:

NCT02208700

Conditions

Acute Lung Injury

Mechanical Ventilation Complication

Dietary Modification

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Oxepa

Jevity 1.5

Study Details

Brief 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.

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.

Conditions

Acute Lung Injury

Mechanical Ventilation Complication

Dietary Modification

Study ID

NCT02208700

Start date

Jan, 2014

Status verified date

Aug, 2014

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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%

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Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oxepa

Other: Therapeutic nutrition with EPA, GLA and antioxidants.

active comparator: Jevity 1.5

Other: Jevity 1.5 Complete Balanced Nutrition with Fiber .

Interventions

Oxepa

Therapeutic nutrition with EPA, GLA< and antioxidants

Jevity 1.5

Complete balanced nutrition with a unique fiber blend

Primary outcome measure

  • Length of days on mechanical ventilation [ Time Frame: 14 days from start of enteral feeding ]

Central Contacts and Locations

Locations

Grace Hospital

Recruiting

Cleveland, Ohio, United States, 44111

Contacts

Carol Gorbach-Melchioris, MEd, RDNLD

216-476-2704cgorbach-melchhioris@gracehospital.org

Principal Investigator:

Basma Ricaurte, MD

More Information

Sponsor

Grace Hospital, Cleveland, Ohio

Last update posted

Aug 5, 2014

Last verified

Aug, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Grace Hospital, Cleveland, Ohio on 2014-08-05.