Timing of Target Enteral Feeding in the Mechanically Ventilated Patient

NCT ID: NCT00252616

Last Updated: 2013-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2009-10-31

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.

Conditions

Acute Respiratory Failure

Keywords

Mechanical ventilation; acute respiratory failure; early nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

trophic feeds

Group Type: EXPERIMENTAL

trophic enteral feeds

Intervention Type: BEHAVIORAL

10cc/hr

2

Full-calorie feeds

Group Type: ACTIVE_COMPARATOR

trophic enteral feeds

Intervention Type: BEHAVIORAL

10cc/hr

Interventions

trophic enteral feeds

10cc/hr

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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.

• 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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Todd Rice

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Todd W Rice, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University School of Medicine

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21242788 (View on PubMed)

Other Identifiers

020744

Identifier Type: -

Identifier Source: org_study_id