Effect of Enteral Nutrition Support for Critically Ill Patients

Study Overview
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Brief Summary
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To determine whether specialized enteral nutrition support can improve oxygenation status in critically ill patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) comparing to a standard enteral nutritional formula.

Official Title
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Effect of Enteral Nutrition Support for Critically Ill Patients

Conditions
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Respiratory Distress Syndrome,Adult, Acute Lung Injury

Intervention / Treatment
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* Other: Enteral nutrition with fatty acids
* Other: Standard Enteral Nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female. ALI or ARDS PaO2/FiO2 > 100 and ≤ 300 torr. Evidence of bilateral pulmonary infiltrates/opacity on chest radiograph. Enteral access Systemic inflammatory response syndrome (SIRS) - two or more of the following must be present: Body temperature less than 36°C or greater than 38°C Heart rate > 90 beats per minute Tachypnea with > 20 breaths per minute; or an arterial partial pressure of carbon dioxide < 4.3 kPa (32 mmHg) White blood cell count < 4000 cells/mm³ or > 12,000 cells/mm³; or the presence of > 10% immature neutrophils. Exclusion Criteria: Dialysis for renal failure Unable to initiate Enteral feeding within 48 hours since all inclusion criteria met. Anticipated life expectancy less than 24 hours. Patient with severe chronic liver disease Neuromuscular disease that impairs ability to ventilate without assistance Head trauma and/or drowning with a Glasgow coma score of 5 Receiving intravenous lipid emulsions from parenteral nutrition within 12 hours of baseline. Receiving propofol Airway reconstructive surgery. Malignancy or irreversible disease for which 6-month mortality is greater than 50%. Burns greater than 25% total body surface area. Unwillingness or inability to utilize the ARDS network ventilation protocol. HIV positive. Chronic mechanical ventilation. Severe, acute pancreatitis. Refractory shock Congestive heart failure with pulmonary edema as the primary cause of hypoxemia. Acute myocardial infarction or cardiac surgery within 7 days. Solid organ transplant. INR > 5.0 or platelet count < 30,000/mm3 or history of bleeding disorder. Intracranial hemorrhage within the past 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Specialized Enteral Nutrition<br>Enteral Feeding to provide 25 kcal/Kg/day | Other: Enteral nutrition with fatty acids<br>* Enteral Feeding to provide 25 kcal/Kg/day<br>|
| Active Comparator: Standard Enteral Nutrition<br>Enteral Feeding to provide 25 kcal/Kg/day | Other: Standard Enteral Nutrition<br>* Enteral Feeding to provide 25 kcal/Kg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation status improvement |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ventilation |  | 28 days | 
| Length of ICU stay |  | 28 days | 
| Incidence of organ failures |  | 28 days | 
| Incidence of ventilator-associated pneumonia |  | 28 days | 
| Mortality |  | 28 days | 
| Glycemic control |  | 28 days | 
| Inflammation |  | 28 days | 
| Vitamin D status |  | 28 days |