Acute Lung Injury, Respiratory Distress Syndrome,Adult
Conditions
Brief summary
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.
Interventions
OTHEREnteral nutrition with fatty acids
Enteral Feeding to provide 25 kcal/Kg/day
Enteral Feeding to provide 25 kcal/Kg/day
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxygenation status improvement | 28 days |
Secondary
| Measure | 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 |
Countries
Russia
Outcome results
None listed