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Efficacy of Oxepa Enteral Feeding in LTAC (Long Term Acute Care Hospital) Patients on Chronic Ventilation- a Pilot Study (ANUS1305)

Primary Purpose

Acute Lung Injury, Mechanical Ventilation Complication, Dietary Modification

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxepa
Jevity 1.5
Sponsored by
Grace Hospital, Cleveland, Ohio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Grace HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxepa

Jevity 1.5

Arm Description

Other: Therapeutic nutrition with EPA, GLA and antioxidants.

Other: Jevity 1.5 Complete Balanced Nutrition with Fiber .

Outcomes

Primary Outcome Measures

Length of days on mechanical ventilation

Secondary Outcome Measures

Full Information

First Posted
August 1, 2014
Last Updated
August 1, 2014
Sponsor
Grace Hospital, Cleveland, Ohio
Collaborators
Abbott Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT02208700
Brief Title
Efficacy of Oxepa Enteral Feeding in LTAC (Long Term Acute Care Hospital) Patients on Chronic Ventilation- a Pilot Study
Acronym
ANUS1305
Official Title
Efficacy of the Use of Enteral Feeding High in EPA,GLA and Antioxidants in LTAC Patients on Chronic Ventilation- a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grace Hospital, Cleveland, Ohio
Collaborators
Abbott Nutrition

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Mechanical Ventilation Complication, Dietary Modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxepa
Arm Type
Experimental
Arm Description
Other: Therapeutic nutrition with EPA, GLA and antioxidants.
Arm Title
Jevity 1.5
Arm Type
Active Comparator
Arm Description
Other: Jevity 1.5 Complete Balanced Nutrition with Fiber .
Intervention Type
Other
Intervention Name(s)
Oxepa
Intervention Description
Therapeutic nutrition with EPA, GLA< and antioxidants
Intervention Type
Other
Intervention Name(s)
Jevity 1.5
Intervention Description
Complete balanced nutrition with a unique fiber blend
Primary Outcome Measure Information:
Title
Length of days on mechanical ventilation
Time Frame
14 days from start of enteral feeding

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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% -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Basma Ricaurte, MD
Organizational Affiliation
Grace Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grace Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Gorbach-Melchioris, MEd, RDNLD
Phone
216-476-2704
Email
cgorbach-melchhioris@gracehospital.org
First Name & Middle Initial & Last Name & Degree
Basma Ricaurte, MD

12. IPD Sharing Statement

Learn more about this trial

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

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