Timing of Target Enteral Feeding in the Mechanically Ventilated Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00252616
Recruitment Status : Completed
First Posted : November 11, 2005
Last Update Posted : December 17, 2013
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Behavioral: trophic enteral feeds Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of Early vs. Delayed Goal Enteral Nutrition in Mechanically Ventilated Patients
Study Start Date : September 2003
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: 1
trophic feeds
Behavioral: trophic enteral feeds

Active Comparator: 2
Full-calorie feeds
Behavioral: trophic enteral feeds

Primary Outcome Measures :
  1. Ventilator-free days [ Time Frame: day 28 ]

Secondary Outcome Measures :
  1. ICU-free days [ Time Frame: day 28 ]
  2. Mortality [ Time Frame: 28 days ]
  3. Incidence of Gastrointestinal intolerances [ Time Frame: day 14 ]
  4. Organ failure-free days [ Time Frame: day 28 ]
  5. Changes in inflammation as measured by serum cytokine levels [ Time Frame: baseline vs. days 6 and 12 ]
  6. Changes in levels of nutrition as measured by serum albumin, total protein, and pre-albumin [ Time Frame: baseline vs. days 6 or 12 ]

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00252616

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Institutes of Health (NIH)
Principal Investigator: Todd W Rice, MD, MSc Vanderbilt University School of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Todd Rice, Assistant Professor, Vanderbilt University Identifier: NCT00252616     History of Changes
Other Study ID Numbers: 020744
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by Todd Rice, Vanderbilt University:
Mechanical ventilation
acute respiratory failure
early nutrition

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases