Clinical trial NCT00252616: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Respiratory Failure
Keywords: Mechanical ventilation
acute respiratory failure
early nutrition
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-11-11
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ventilator-free days
timeFrame: day 28
Secondary outcomes:
measure: ICU-free days
timeFrame: day 28
measure: Mortality
timeFrame: 28 days
measure: Incidence of Gastrointestinal intolerances
timeFrame: day 14
measure: Organ failure-free days
timeFrame: day 28
measure: Changes in inflammation as measured by serum cytokine levels
timeFrame: baseline vs. days 6 and 12
measure: Changes in levels of nutrition as measured by serum albumin, total protein, and pre-albumin
timeFrame: baseline vs. days 6 or 12
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Medicine
name: Todd W Rice, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.