Effect of Enteral Nutrition Support for Critically Ill Patients

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2011

Interventions

  • Other: Enteral nutrition with fatty acids
    • Enteral Feeding to provide 25 kcal/Kg/day
  • Other: Standard Enteral Nutrition
    • Enteral Feeding to provide 25 kcal/Kg/day

Arms, Groups and Cohorts

  • Experimental: Specialized Enteral Nutrition
    • Enteral Feeding to provide 25 kcal/Kg/day
  • Active Comparator: Standard Enteral Nutrition
    • Enteral Feeding to provide 25 kcal/Kg/day

Clinical Trial Outcome Measures

Primary Measures

  • Oxygenation status improvement
    • Time Frame: 28 days

Secondary Measures

  • Length of ventilation
    • Time Frame: 28 days
  • Length of ICU stay
    • Time Frame: 28 days
  • Incidence of organ failures
    • Time Frame: 28 days
  • Incidence of ventilator-associated pneumonia
    • Time Frame: 28 days
  • Mortality
    • Time Frame: 28 days
  • Glycemic control
    • Time Frame: 28 days
  • Inflammation
    • Time Frame: 28 days
  • Vitamin D status
    • Time Frame: 28 days

Participating in This Clinical Trial

Inclusion Criteria

1. Male or non-pregnant female. 2. ALI or ARDS 3. PaO2/FiO2 > 100 and ≤ 300 torr. 4. Evidence of bilateral pulmonary infiltrates/opacity on chest radiograph. 5. Enteral access 6. Systemic inflammatory response syndrome (SIRS) – two or more of the following must be present: 1. Body temperature less than 36°C or greater than 38°C 2. Heart rate > 90 beats per minute 3. Tachypnea with > 20 breaths per minute; or an arterial partial pressure of carbon dioxide < 4.3 kPa (32 mmHg) 4. White blood cell count < 4000 cells/mm³ or > 12,000 cells/mm³; or the presence of > 10% immature neutrophils. Exclusion Criteria:

1. Dialysis for renal failure 2. Unable to initiate Enteral feeding within 48 hours since all inclusion criteria met. 3. Anticipated life expectancy less than 24 hours. 4. Patient with severe chronic liver disease 5. Neuromuscular disease that impairs ability to ventilate without assistance 6. Head trauma and/or drowning with a Glasgow coma score of 5 7. Receiving intravenous lipid emulsions from parenteral nutrition within 12 hours of baseline. 8. Receiving propofol 9. Airway reconstructive surgery. 10. Malignancy or irreversible disease for which 6-month mortality is greater than 50%. 11. Burns greater than 25% total body surface area. 12. Unwillingness or inability to utilize the ARDS network ventilation protocol. 13. HIV positive. 14. Chronic mechanical ventilation. 15. Severe, acute pancreatitis. 16. Refractory shock 17. Congestive heart failure with pulmonary edema as the primary cause of hypoxemia. 18. Acute myocardial infarction or cardiac surgery within 7 days. 19. Solid organ transplant. 20. INR > 5.0 or platelet count < 30,000/mm3 or history of bleeding disorder. 21. Intracranial hemorrhage within the past 30 days.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott Nutrition
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Menghua Luo, MD, PhD, Study Chair, Abbott Nutrition

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