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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

Primary Purpose

Critical Illness, Enteral Feeding

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

VITAL AF

Osmolite 1.2

About this trial

This is an interventional prevention trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

NewYork-Presbyterian Hospital at Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vital AF

Osmolite 1.2

Arm Description

Outcomes

Primary Outcome Measures

Improved tolerance to enteral (tube) feeding

Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.

Secondary Outcome Measures

Improved delivery of prescribed calories

Measurement of volume of feeding product actually delivered to patient is part of the daily flow-sheet data.

Decreased incidence of complications

Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.

Full Information

NCT ID

NCT01448135

First Posted

October 3, 2011

Last Updated

June 22, 2015

Sponsor

Columbia University

Collaborators

Abbott Nutrition

1. Study Identification

Unique Protocol Identification Number

NCT01448135

Brief Title

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

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

Abbott Nutrition

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness, Enteral Feeding

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vital AF

Arm Type

Experimental

Arm Title

Osmolite 1.2

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

VITAL AF

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Osmolite 1.2

Intervention Description

High protein enteral formula

Primary Outcome Measure Information:

Title

Improved tolerance to enteral (tube) feeding

Description

Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.

Time Frame

Baseline and 21 Days

Secondary Outcome Measure Information:

Title

Improved delivery of prescribed calories

Description

Measurement of volume of feeding product actually delivered to patient is part of the daily flow-sheet data.

Time Frame

Baseline and 21 Days

Title

Decreased incidence of complications

Description

Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.

Time Frame

Baseline and 21 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ira J Goldberg, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

NewYork-Presbyterian Hospital at Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27161892

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.

Results Reference

derived

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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

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