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Timing of Target Enteral Feeding in the Mechanically Ventilated Patient

Primary Purpose

Acute Respiratory Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
trophic enteral feeds
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring Mechanical ventilation, acute respiratory failure, early nutrition

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients will be eligible for inclusion in the study if they meet the following criteria: Mechanical ventilation expected to last at least 72 hours. Presence of, or primary physician's intent to place, an enteral feeding tube and begin enteral feeds. Exclusion Criteria: More than 48 hours elapsed since both inclusion criteria met. Patient, legal representative, or physician refuses consent or is unavailable to provide consent. Patient, legal representative, or physician not committed to full support (Exception: A patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest). Presence of malignant or irreversible condition and estimated 28 day mortality greater than 50%. Severe or refractory shock. Moribund patients not expected to survive 24 hours from start of enteral feeding (as determined by primary medical team). Child-Pugh score greater than 10. Presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction. Current TPN use or intent to use TPN within 7 days. Severe malnutrition with BMI less than 18.5 and/or loss of more than 30% total body weight in the previous 6 months. Neuromuscular disease impairing the ability to ventilate spontaneously. Laparotomy expected within 7 days. Unable to raise head of bed 45°. greater than 30% total body surface area burns. Absence of GI tract/short bowel syndrome - defined as entire length of small bowel totaling 4 feet or less. Presence of high-output (> 500 cc/day) enterocutaneous fistula. Age less than 13 years Allergy to enteral formula

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

trophic feeds

Full-calorie feeds

Outcomes

Primary Outcome Measures

Ventilator-free days

Secondary Outcome Measures

ICU-free days
Mortality
Incidence of Gastrointestinal intolerances
Organ failure-free days
Changes in inflammation as measured by serum cytokine levels
Changes in levels of nutrition as measured by serum albumin, total protein, and pre-albumin

Full Information

First Posted
November 9, 2005
Last Updated
December 16, 2013
Sponsor
Vanderbilt University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00252616
Brief Title
Timing of Target Enteral Feeding in the Mechanically Ventilated Patient
Official Title
Phase III Study of Early vs. Delayed Goal Enteral Nutrition in Mechanically Ventilated Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study tests the hypothesis that initial trophic enteral feedings will increase the time alive and free of mechanical ventilation as compared to initial goal enteral feedings in patients who are mechanically ventilated.
Detailed Description
Mechanically ventilated patients, within 48 hours of initiating mechanical ventilation, are randomized in a 1:1 fashion to receive trophic enteral feedings for 96 hours followed by advancement to goal feeding rates or initial advancement to goal feeding rates. Primary endpoints are ventilator free days, ICU-free days, gastrointestinal intolerances, development of nosocomial infections, and mortality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
Mechanical ventilation, acute respiratory failure, early nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
trophic feeds
Arm Title
2
Arm Type
Active Comparator
Arm Description
Full-calorie feeds
Intervention Type
Behavioral
Intervention Name(s)
trophic enteral feeds
Intervention Description
10cc/hr
Primary Outcome Measure Information:
Title
Ventilator-free days
Time Frame
day 28
Secondary Outcome Measure Information:
Title
ICU-free days
Time Frame
day 28
Title
Mortality
Time Frame
28 days
Title
Incidence of Gastrointestinal intolerances
Time Frame
day 14
Title
Organ failure-free days
Time Frame
day 28
Title
Changes in inflammation as measured by serum cytokine levels
Time Frame
baseline vs. days 6 and 12
Title
Changes in levels of nutrition as measured by serum albumin, total protein, and pre-albumin
Time Frame
baseline vs. days 6 or 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be eligible for inclusion in the study if they meet the following criteria: Mechanical ventilation expected to last at least 72 hours. Presence of, or primary physician's intent to place, an enteral feeding tube and begin enteral feeds. Exclusion Criteria: More than 48 hours elapsed since both inclusion criteria met. Patient, legal representative, or physician refuses consent or is unavailable to provide consent. Patient, legal representative, or physician not committed to full support (Exception: A patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest). Presence of malignant or irreversible condition and estimated 28 day mortality greater than 50%. Severe or refractory shock. Moribund patients not expected to survive 24 hours from start of enteral feeding (as determined by primary medical team). Child-Pugh score greater than 10. Presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction. Current TPN use or intent to use TPN within 7 days. Severe malnutrition with BMI less than 18.5 and/or loss of more than 30% total body weight in the previous 6 months. Neuromuscular disease impairing the ability to ventilate spontaneously. Laparotomy expected within 7 days. Unable to raise head of bed 45°. greater than 30% total body surface area burns. Absence of GI tract/short bowel syndrome - defined as entire length of small bowel totaling 4 feet or less. Presence of high-output (> 500 cc/day) enterocutaneous fistula. Age less than 13 years Allergy to enteral formula
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd W Rice, MD, MSc
Organizational Affiliation
Vanderbilt University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21242788
Citation
Rice TW, Mogan S, Hays MA, Bernard GR, Jensen GL, Wheeler AP. Randomized trial of initial trophic versus full-energy enteral nutrition in mechanically ventilated patients with acute respiratory failure. Crit Care Med. 2011 May;39(5):967-74. doi: 10.1097/CCM.0b013e31820a905a.
Results Reference
derived

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Timing of Target Enteral Feeding in the Mechanically Ventilated Patient

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