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Completed

NCT Number: NCT00252616

Timing of Target Enteral Feeding in the Mechanically Ventilated Patient

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.

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

trophic enteral feeds

Behavioral

10cc/hr

Primary outcomes

  1. Ventilator-free days

    Time frame: day 28

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Phase III Study of Early vs. Delayed Goal Enteral Nutrition in Mechanically Ventilated Patients

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Nov 11, 2005
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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