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 Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vital AF
|
Other: VITAL AF
Semi-elemental, high protein, and high omega-3 fish oil enteral formula
|
| Active Comparator: Osmolite 1.2
|
Other: Osmolite 1.2
High protein enteral formula
|
Outcome Measures
Primary Outcome Measures
- Improved tolerance to enteral (tube) feeding [Baseline and 21 Days]
Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.
Secondary Outcome Measures
- Improved delivery of prescribed calories [Baseline and 21 Days]
Measurement of volume of feeding product actually delivered to patient is part of the daily flow-sheet data.
- Decreased incidence of complications [Baseline and 21 Days]
Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NewYork-Presbyterian Hospital at Columbia University Medical Center | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
- Abbott Nutrition
Investigators
- Principal Investigator: Ira J Goldberg, MD, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAI1205
- ANUS1015