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Effect of Enteral Nutrition Support for Critically Ill Patients

This study has been terminated.
(Interim analysis indicated significant additional subjects needed to demonsate statistical difference in primary outcome.)
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01464853
First received: November 1, 2011
Last updated: November 2, 2011
Last verified: March 2011

November 1, 2011
November 2, 2011
April 2010
April 2011   (final data collection date for primary outcome measure)
Oxygenation status improvement [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01464853 on ClinicalTrials.gov Archive Site
  • Length of ventilation [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Length of ICU stay [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Incidence of organ failures [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Incidence of ventilator-associated pneumonia [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Glycemic control [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Inflammation [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Vitamin D status [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Enteral Nutrition Support for Critically Ill Patients
Effect of Enteral Nutrition Support for Critically Ill Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Respiratory Distress Syndrome,Adult
  • Acute Lung Injury
  • 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
  • Experimental: Specialized Enteral Nutrition
    Enteral Feeding to provide 25 kcal/Kg/day
    Intervention: Other: Enteral nutrition with fatty acids
  • Active Comparator: Standard Enteral Nutrition
    Enteral Feeding to provide 25 kcal/Kg/day
    Intervention: Other: Standard Enteral Nutrition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
84
May 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01464853
BK54
No
Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Menghua Luo, MD, PhD Abbott Nutrition
Abbott Nutrition
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP