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

Not Applicable

Completed

• Conditions: Enteral Feeding; Critical Illness
• Interventions: Other: VITAL AF; Other: Osmolite 1.2

• Registration Number: NCT01448135
• Lead Sponsor: Columbia University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-07
• Status Verified: 2014-01
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vital AF	VITAL AF	-
Osmolite 1.2	Osmolite 1.2	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improved delivery of prescribed calories	Baseline and 21 Days	Measurement of volume of feeding product actually delivered to patient is part of the daily flow-sheet data.
Decreased incidence of complications	Baseline and 21 Days	Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.

Trial Locations

Locations (1)

NewYork-Presbyterian Hospital at Columbia University Medical Center; 🇺🇸 New York, New York, United States