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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

This study is currently recruiting participants.
Verified July 2012 by Columbia University
Sponsor:
Collaborator:
Abbott Nutrition
Information provided by (Responsible Party):
David Seres, Columbia University
ClinicalTrials.gov Identifier:
NCT01448135
First received: October 3, 2011
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Critical Illness
Enteral Feeding
 Other: VITAL AF
Other: Osmolite 1.2

Study Type: Interventional
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is receiving mechanical ventilation and 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 19

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448135

Contacts
Contact: David S Seres, MD, ScM 212-342-3112 dseres@columbia.edu
Contact: Paul R Ippolito, BS pi2123@columbia.edu

Locations
United States, New York
NewYork-Presbyterian Hospital at Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Abbott Nutrition
  More Information

No publications provided

Responsible Party: David Seres, Assistant Professor of Clinical Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01448135     History of Changes
Other Study ID Numbers: AAAI1205, ANUS1015
Study First Received: October 3, 2011
Last Updated: July 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013