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

Critical Illness Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448135
• Other study ID #: AAAI1205
• Secondary ID: ANUS1015
• Status: Completed
• Phase: N/A
• First received: October 3, 2011
• Last updated: June 22, 2015
• Start date: October 2011
• Est. completion date: November 2014

Study information

• Verified date: January 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Enteral Feeding

Intervention

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

Locations

Country	Name	City	State
United States	NewYork-Presbyterian Hospital at Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved tolerance to enteral (tube) feeding	Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.	Baseline and 21 Days	Yes
Secondary	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	Yes
Secondary	Decreased incidence of complications	Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.	Baseline and 21 Days	Yes