Timing of Target Enteral Feeding in the Mechanically Ventilated Patient

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Behavioral: trophic enteral feeds


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>trophic feeds | Behavioral: trophic enteral feeds<br>* 10cc/hr<br>|
| Active Comparator: 2<br>Full-calorie feeds | Behavioral: trophic enteral feeds<br>* 10cc/hr<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-free days |  | day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Changes in levels of nutrition as measured by serum albumin, total protein, and pre-albumin |  | baseline vs. days 6 or 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, acute respiratory failure, early nutrition