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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study Evaluating the Efficacy, Tolerance and Safety of VITAL AF (Semi Elemental, High Protein, High Omega 3 Fat Enteral Formula) Versus Osmolite 1.2 (High Protein Enteral Formula) in Multiple ICU Settings (Medical, Surgical, Cardiothoracic)

Conditions
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Critical Illness, Enteral Feeding

Intervention / Treatment
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* Other: VITAL AF
* Other: Osmolite 1.2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vital AF<br> | Other: VITAL AF<br>* Semi-elemental, high protein, and high omega-3 fish oil enteral formula<br>|
| Active Comparator: Osmolite 1.2<br> | Other: Osmolite 1.2<br>* High protein enteral formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved tolerance to enteral (tube) feeding | Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc. | Baseline and 21 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Decreased incidence of complications | Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc. | Baseline and 21 Days |