Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ANUS1015 | Other Grant/Funding Number | ABBOTT Nutrition |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott Nutrition | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vital AF | Experimental |
| |
| Osmolite 1.2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VITAL AF | Other | Semi-elemental, high protein, and high omega-3 fish oil enteral formula |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improved tolerance to enteral (tube) feeding | Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc. | Baseline and 21 Days |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ira J Goldberg, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NewYork-Presbyterian Hospital at Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27161892 | Derived | Seres DS, Ippolito PR. Pilot study evaluating the efficacy, tolerance and safety of a peptide-based enteral formula versus a high protein enteral formula in multiple ICU settings (medical, surgical, cardiothoracic). Clin Nutr. 2017 Jun;36(3):706-709. doi: 10.1016/j.clnu.2016.04.016. Epub 2016 Apr 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Osmolite 1.2 |
| Other |
High protein enteral formula |
|
Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.
| Baseline and 21 Days |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided