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Effect of Enteral Nutrition Support for Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT01464853
Recruitment Status : Terminated (Interim analysis indicated significant additional subjects needed to demonsate statistical difference in primary outcome.)
First Posted : November 4, 2011
Last Update Posted : November 4, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Enteral Nutrition Support for Critically Ill Patients
Study Start Date : April 2010
Primary Completion Date : April 2011
Study Completion Date : May 2011


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Oxygenation status improvement [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Length of ventilation [ Time Frame: 28 days ]
  2. Length of ICU stay [ Time Frame: 28 days ]
  3. Incidence of organ failures [ Time Frame: 28 days ]
  4. Incidence of ventilator-associated pneumonia [ Time Frame: 28 days ]
  5. Mortality [ Time Frame: 28 days ]
  6. Glycemic control [ Time Frame: 28 days ]
  7. Inflammation [ Time Frame: 28 days ]
  8. Vitamin D status [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01464853     History of Changes
Other Study ID Numbers: BK54
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: November 4, 2011
Last Verified: March 2011

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