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Timing of Target Enteral Feeding in the Mechanically Ventilated Patient

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00252616
First received: November 9, 2005
Last updated: January 13, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Failure
 Behavioral: trophic enteral feeds
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Early vs. Delayed Goal Enteral Nutrition in Mechanically Ventilated Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Ventilator-free days [ Time Frame: day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU-free days [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Incidence of Gastrointestinal intolerances [ Time Frame: day 14 ] [ Designated as safety issue: No ]
  • Organ failure-free days [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • Changes in inflammation as measured by serum cytokine levels [ Time Frame: baseline vs. days 6 and 12 ] [ Designated as safety issue: No ]
  • Changes in levels of nutrition as measured by serum albumin, total protein, and pre-albumin [ Time Frame: baseline vs. days 6 or 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2003
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
trophic feeds
 Behavioral: trophic enteral feeds
10cc/hr
Active Comparator: 2
Full-calorie feeds
 Behavioral: trophic enteral feeds
10cc/hr

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252616

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Todd W Rice, MD, MSc Vanderbilt University School of Medicine
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Todd W. Rice, MD, MSc, Division of Allergy, Pulmonary, and Critical Care Medicine
ClinicalTrials.gov Identifier: NCT00252616     History of Changes
Other Study ID Numbers: 020744
Study First Received: November 9, 2005
Last Updated: January 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Mechanical ventilation
acute respiratory failure
early nutrition

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on May 16, 2013