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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01448135
Other study ID # AAAI1205
Secondary ID ANUS1015
Status Completed
Phase N/A
First received October 3, 2011
Last updated June 22, 2015
Start date October 2011
Est. completion date November 2014

Study information

Verified date January 2014
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this pilot study is to assess the efficacy, safety and tolerance profile of the enteral feeding product VITAL AF (a semi-elemental, high protein, and high omega-3 fish oil) when compared to Osmolite 1.2, a standard feeding product in critically ill and/or post surgical patients in the intensive care unit (ICU). If enough patients are recruited, inferences about impact on outcomes may also be drawn.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject requires enteral tube feeding as sole source of nourishment

- Subject, or subject's legally acceptable representative (LAR), has provided voluntarily and informed consent form, as deemed appropriate and approved by the Columbia University Medical Center Institutional Review Board

- Subject is = 18 years of age

- Subject is male or non-pregnant female at least six weeks postpartum and non-lactating females of childbearing potential will be required to confirm non-pregnancy status with a pregnancy test at screening

- Subject has an initial APACHE II score less than or equal to 24

Exclusion Criteria:

- Subject requires parenteral nutrition

- Subject is acutely impacted or constipated

- Subject has intestinal obstruction

- Subject is too hemodynamically unstable for enteral feeding

- Subject has an allergy or intolerance to any ingredient in the study product by documentation or verbal report by subject or subject's LAR

- Subject is participating in a non-Abbott approved concomitant trial

- Subject has gastrointestinal disease, including acute pancreatitis, active gastrointestinal bleeding, acute inflammatory bowel disease, or has undergone intestinal surgery within the past month

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
VITAL AF
Semi-elemental, high protein, and high omega-3 fish oil enteral formula
Osmolite 1.2
High protein enteral formula

Locations

Country Name City State
United States NewYork-Presbyterian Hospital at Columbia University Medical Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Columbia University Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improved tolerance to enteral (tube) feeding Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc. Baseline and 21 Days Yes
Secondary Improved delivery of prescribed calories Measurement of volume of feeding product actually delivered to patient is part of the daily flow-sheet data. Baseline and 21 Days Yes
Secondary Decreased incidence of complications Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc. Baseline and 21 Days Yes
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