NCT02208700

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

1.7 years

First QC Date

August 1, 2014

Last Update Submit

August 1, 2014

Conditions

Acute Lung InjuryMechanical Ventilation ComplicationDietary Modification

Outcome Measures

Primary Outcomes (1)

  • Length of days on mechanical ventilation

    14 days from start of enteral feeding

Study Arms (2)

Oxepa

EXPERIMENTAL

Other: Therapeutic nutrition with EPA, GLA and antioxidants.

Other: Oxepa

Jevity 1.5

ACTIVE COMPARATOR

Other: Jevity 1.5 Complete Balanced Nutrition with Fiber .

Other: Jevity 1.5

Interventions

OxepaOTHER

Therapeutic nutrition with EPA, GLA\< and antioxidants

Oxepa
Jevity 1.5OTHER

Complete balanced nutrition with a unique fiber blend

Jevity 1.5

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grace Hospital

Cleveland, Ohio, 44111, United States

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Basma Ricaurte, MD

    Grace Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2014

First Posted

August 5, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2015

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

US(1)