Efficacy of Oxepa Enteral Feeding in LTAC (Long Term Acute Care Hospital) Patients on Chronic Ventilation- a Pilot Study

NCT ID: NCT02208700

Last Updated: 2014-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lung Injury Mechanical Ventilation Complication Dietary Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxepa

Other: Therapeutic nutrition with EPA, GLA and antioxidants.

Group Type EXPERIMENTAL

Oxepa

Intervention Type OTHER

Therapeutic nutrition with EPA, GLA\< and antioxidants

Jevity 1.5

Other: Jevity 1.5 Complete Balanced Nutrition with Fiber .

Group Type ACTIVE_COMPARATOR

Jevity 1.5

Intervention Type OTHER

Complete balanced nutrition with a unique fiber blend

Interventions

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Oxepa

Therapeutic nutrition with EPA, GLA\< and antioxidants

Intervention Type OTHER

Jevity 1.5

Complete balanced nutrition with a unique fiber blend

Intervention Type OTHER

Eligibility Criteria

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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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Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role collaborator

Grace Hospital, Cleveland, Ohio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Basma Ricaurte, MD

Role: PRINCIPAL_INVESTIGATOR

Grace Hospital

Locations

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Grace Hospital

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Carol Gorbach-Melchioris, MEd, RDNLD

Role: primary

216-476-2704

Other Identifiers

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1141459

Identifier Type: -

Identifier Source: org_study_id

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