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NCT02208700 Clinical Trial

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

Mechanical Ventilation Complication Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02208700
Other study ID # 1141459
Secondary ID
Status Recruiting
Phase N/A
First received August 1, 2014
Last updated August 1, 2014
Start date January 2014

Study information
Verified date August 2014
Source Grace Hospital, Cleveland, Ohio
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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%

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Oxepa
Therapeutic nutrition with EPA, GLA< and antioxidants
• Jevity 1.5
Complete balanced nutrition with a unique fiber blend

Locations
Country Name City State
United States Grace Hospital Cleveland Ohio

Sponsors (2)
Lead Sponsor Collaborator
Grace Hospital, Cleveland, Ohio Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Length of days on mechanical ventilation 14 days from start of enteral feeding No
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