Timing of Target Enteral Feeding in the Mechanically Ventilated Patient

NCT00252616 | Completed Phase 2 DMC

• 1 other identifier: 020744
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Keywords

Mechanical ventilation; acute respiratory failure; early nutrition

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days

  day 28

Secondary Outcomes (6)

• ICU-free days

  day 28

• Mortality

  28 days

• 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

Study Arms (2)

1

EXPERIMENTAL

trophic feeds

Behavioral: trophic enteral feeds

2

ACTIVE COMPARATOR

Full-calorie feeds

Behavioral: trophic enteral feeds

Interventions

trophic enteral feeds BEHAVIORAL

10cc/hr

1; 2

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 21242788 DERIVED

Study Officials

• Todd W Rice, MD, MSc

  Vanderbilt University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: September 1, 2003
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

US (1)