NCT01464853
Terminated
Phase 3
Effect of Enteral Nutrition Support for Critically Ill Patients
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Respiratory Distress Syndrome,Adult
- Sponsor
- Abbott Nutrition
- Enrollment
- 84
- Locations
- 9
- Primary Endpoint
- Oxygenation status improvement
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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%.
Outcomes
Primary Outcomes
Oxygenation status improvement
Time Frame: 28 days
Secondary Outcomes
- Vitamin D status(28 days)
- 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)
Study Sites (9)
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