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

Columbia University

Status

Completed

Conditions

Enteral Feeding

Critical Illness

Treatments

Other: Osmolite 1.2

Other: VITAL AF

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01448135

ANUS1015 (Other Grant/Funding Number)

AAAI1205

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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