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

June 22, 2015 updated by: Ira Jay Goldberg, Columbia University

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • NewYork-Presbyterian Hospital at Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved tolerance to enteral (tube) feeding
Time Frame: Baseline and 21 Days
Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.
Baseline and 21 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 21 Days
Decreased incidence of complications
Time Frame: Baseline and 21 Days
Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.
Baseline and 21 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Abbott Nutrition

Investigators

  • Principal Investigator: Ira J Goldberg, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

October 5, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAI1205
  • ANUS1015 (Other Grant/Funding Number: ABBOTT Nutrition)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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