Timing of Target Enteral Feeding in the Mechanically Ventilated Patient

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252616
• Other study ID #: 020744
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 9, 2005
• Last updated: December 16, 2013
• Start date: September 2003
• Est. completion date: October 2009

Study information

• Verified date: December 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Behavioral:
• trophic enteral feeds
10cc/hr

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-free days		day 28	No
Secondary	ICU-free days		day 28	No
Secondary	Mortality		28 days	No
Secondary	Incidence of Gastrointestinal intolerances		day 14	No
Secondary	Organ failure-free days		day 28	No
Secondary	Changes in inflammation as measured by serum cytokine levels		baseline vs. days 6 and 12	No
Secondary	Changes in levels of nutrition as measured by serum albumin, total protein, and pre-albumin		baseline vs. days 6 or 12	No