Status:
TERMINATED
Effect of Enteral Nutrition Support for Critically Ill Patients
Lead Sponsor:
Abbott Nutrition
Conditions:
Respiratory Distress Syndrome,Adult
Acute Lung Injury
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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) comparin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01464853
Start Date
April 1 2010
End Date
May 1 2011
Last Update
November 4 2011
Active Locations (9)
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1
1st City Clinical Emergency Hospital n.a. E.E. Volosevich
Arkhangelsk, Russia, 163001
2
City Clinical Hospital #2
Krasnodar, Russia, 350012
3
Krasnoyarsk State Medical University n.a. Prof V.F. Voyno-Yasenetskogo
Krasnoyarsk, Russia, 660022
4
Central Clinical Hospital #1
Moscow, Russia, 125367