Clinical trial 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
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Enteral Feeding
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Abbott Nutrition
First posted: 2011-10-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Improved tolerance to enteral (tube) feeding
timeFrame: Baseline and 21 Days
Secondary outcomes:
measure: Improved delivery of prescribed calories
timeFrame: Baseline and 21 Days
measure: Decreased incidence of complications
timeFrame: Baseline and 21 Days
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork-Presbyterian Hospital at Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Ira J Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seres DS, Ippolito PR. Pilot study evaluating the efficacy, tolerance and safety of a peptide-based enteral formula versus a high protein enteral formula in multiple ICU settings (medical, surgical, cardiothoracic). Clin Nutr. 2017 Jun;36(3):706-709. doi: 10.1016/j.clnu.2016.04.016. Epub 2016 Apr 26.