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OpenTrials
Completed

NCT Number: NCT01448135

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NewYork-Presbyterian Hospital at Columbia University Medical Center

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VITAL AF

Other

Semi-elemental, high protein, and high omega-3 fish oil enteral formula

Osmolite 1.2

Other

High protein enteral formula

Primary outcomes

  1. Improved tolerance to enteral (tube) feeding

    Time frame: Baseline and 21 Days

    Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.

Secondary outcomes

  1. Improved delivery of prescribed calories

    Time frame: Baseline and 21 Days

    Measurement of volume of feeding product actually delivered to patient is part of the daily flow-sheet data.

  2. Decreased incidence of complications

    Time frame: Baseline and 21 Days

    Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Abbott Nutrition

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 7, 2011
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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