Timing of Target Enteral Feeding in the Mechanically Ventilated Patient

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Behavioral: trophic enteral feeds

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
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; trophic feeds	Behavioral: trophic enteral feeds; 10cc/hr
Active Comparator: 2; Full-calorie feeds	Behavioral: trophic enteral feeds; 10cc/hr

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ventilator-free days	day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	28 days
ICU-free days	day 28
Incidence of Gastrointestinal intolerances	day 14
Organ failure-free days	day 28
Changes in inflammation as measured by serum cytokine levels	baseline vs. days 6 and 12
Changes in levels of nutrition as measured by serum albumin, total protein, and pre-albumin	baseline vs. days 6 or 12

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Todd W Rice, MD, MSc, Vanderbilt University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: November 9, 2005
• First Submitted That Met QC Criteria: November 10, 2005
• First Posted (Estimate): November 11, 2005

Study Record Updates

• Last Update Posted (Estimate): December 17, 2013
• Last Update Submitted That Met QC Criteria: December 16, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Mechanical ventilation; acute respiratory failure; early nutrition
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 020744