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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Critical Illness Enteral Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Vital AF

Group Type EXPERIMENTAL

VITAL AF

Intervention Type OTHER

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

Osmolite 1.2

Group Type ACTIVE_COMPARATOR

Osmolite 1.2

Intervention Type OTHER

High protein enteral formula

Interventions

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VITAL AF

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

Intervention Type OTHER

Osmolite 1.2

High protein enteral formula

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No