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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified December 2013 by Columbia University
Sponsor
Columbia University
Information Provided by (Responsible Party)
Ira Jay Goldberg
Clinicaltrials.gov Identifier
NCT01448135
Other Study ID Numbers:
AAAI1205
First Submitted
October 2, 2011
First Posted
October 6, 2011
Last Update Posted
June 22, 2015
Last Verified
December 2013

ClinicalTrials.gov processed this data on June 2015. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Critical IllnessEnteral Feeding
Other: VITAL AFOther: Osmolite 1.2

Study Design

Study TypeInterventional
Actual Enrollment50 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposePrevention
Official TitlePilot 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 Start DateSeptember 30, 2011
Actual Primary Completion DateOctober 31, 2014
Actual Study Completion DateOctober 31, 2014

Groups and Cohorts

Group/CohortIntervention/Treatment
Vital AF
Other: VITAL AF
Semi-elemental, high protein, and high omega-3 fish oil enteral formula
Osmolite 1.2
Other: Osmolite 1.2
High protein enteral formula

Outcome Measures

Primary Outcome Measures
  1. Improved tolerance to enteral (tube) feeding
    Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.
Secondary Outcome Measures
  1. Improved delivery of prescribed calories
    Measurement of volume of feeding product actually delivered to patient is part of the daily flow-sheet data.
  2. Decreased incidence of complications
    Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsColumbia University
Locations
NewYork-Presbyterian Hospital at Columbia University Medical Center | New York New York, United States, 10032
Investigators
Principal Investigator: Ira J Goldberg, MD, Columbia University