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
  Purpose

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.


Condition Intervention Phase
Respiratory Distress Syndrome,Adult
Acute Lung Injury
Other: Enteral nutrition with fatty acids
Other: Standard Enteral Nutrition
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Enteral Nutrition Support for Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Oxygenation status improvement [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 84
Study Start Date: April 2010
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Specialized Enteral Nutrition
Enteral Feeding to provide 25 kcal/Kg/day
Other: Enteral nutrition with fatty acids
Enteral Feeding to provide 25 kcal/Kg/day
Active Comparator: Standard Enteral Nutrition
Enteral Feeding to provide 25 kcal/Kg/day
Other: Standard Enteral Nutrition
Enteral Feeding to provide 25 kcal/Kg/day

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464853

Locations
Russian Federation
1st City Clinical Emergency Hospital n.a. E.E. Volosevich
Arkhangelsk, Russian Federation, 163001
Central City Hospital #7
Ekaterinburg, Russian Federation, 620109
City Clinical Hospital #2
Krasnodar, Russian Federation, 350012
Krasnoyarsk State Medical University n.a. Prof V.F. Voyno-Yasenetskogo
Krasnoyarsk, Russian Federation, 660022
Central Clinical Hospital #1
Moscow, Russian Federation, 125367
State Novosibirsk Regional Clinical Hospital
Novosibirsk, Russian Federation, 630087
Clinical Medical Unit #1
Perm, Russian Federation, 614010
St. Petersburg Scientific Research Institute of Emergency Care n.a. I.I.Dzhanelidze
St. Petersburg, Russian Federation, 192442
Republican Clinical Hospital n.a. G.G. Kuvatova
Ufa, Russian Federation, 45005
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Menghua Luo, MD, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01464853     History of Changes
Other Study ID Numbers: BK54
Study First Received: November 1, 2011
Last Updated: November 2, 2011
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Critical Illness
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Wounds and Injuries
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries

ClinicalTrials.gov processed this record on August 28, 2014