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
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
|Official Title:||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)|
- Improved tolerance to enteral (tube) feeding [ Time Frame: Baseline and 21 Days ] [ Designated as safety issue: Yes ]Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.
- 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.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448135
|Contact: Ira J Goldberg, MDfirstname.lastname@example.org|
|Contact: Paul R Ippolito, BSemail@example.com|
|United States, New York|
|NewYork-Presbyterian Hospital at Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Principal Investigator:||Ira J Goldberg, MD||Columbia University|