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

Completed · Not applicable

Conditions studied: Critical Illness, Enteral Feeding

In brief

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.

Key facts

Study ID

NCT01448135

Run by

Columbia University

People needed

50

Starts

2011-10-01

Expected to finish

2014-11-01

Last updated by the study team

2015-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NewYork-Presbyterian Hospital at Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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