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

Vanderbilt University1 site in 1 country200 target enrollmentSeptember 2003

ConditionsAcute Respiratory Failure

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Acute Respiratory Failure
Sponsor: Vanderbilt University
Enrollment: 200
Locations: 1
Primary Endpoint: Ventilator-free days
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

October 2009

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vanderbilt University

Responsible Party

Principal Investigator

Todd Rice

Assistant Professor

Vanderbilt University

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
•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.

Outcomes

Primary Outcomes

Ventilator-free days

Time Frame: day 28

Secondary Outcomes

Mortality(28 days)
Incidence of Gastrointestinal intolerances(day 14)
Organ failure-free days(day 28)
ICU-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)