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

• Improved delivery of prescribed calories [ Time Frame: Baseline and 21 Days ] [ Designated as safety issue: Yes ]
  Measurement of volume of feeding product actually delivered to patient is part of the daily flow-sheet data.
• Decreased incidence of complications [ Time Frame: Baseline and 21 Days ] [ Designated as safety issue: Yes ]
  Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.

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.

• Critical Illness
• Enteral Feeding

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

• Experimental: Vital AF
  Intervention: Other: VITAL AF
• Active Comparator: Osmolite 1.2
  Intervention: Other: Osmolite 1.2

Inclusion Criteria:

• Subject is receiving mechanical ventilation and 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 19

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