Status:
COMPLETED
Tolerance and Efficacy of a Predigested, High Protein, High Omega 3 Fat Enteral Feeding Formula Versus a Standard Formula In Multiple Intensive Care Unit Settings
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Abbott Nutrition
Conditions:
Critical Illness
Enteral Feeding
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 compare...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01448135
Start Date
October 1 2011
End Date
November 1 2014
Last Update
June 23 2015
Active Locations (1)
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1
NewYork-Presbyterian Hospital at Columbia University Medical Center
New York, New York, United States, 10032