Effect of Enteral Nutrition Support for Critically Ill Patients
NCT ID: NCT01464853
Last Updated: 2011-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
84 participants
INTERVENTIONAL
2010-04-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Specialized Enteral Nutrition
Enteral Feeding to provide 25 kcal/Kg/day
Enteral nutrition with fatty acids
Enteral Feeding to provide 25 kcal/Kg/day
Standard Enteral Nutrition
Enteral Feeding to provide 25 kcal/Kg/day
Standard Enteral Nutrition
Enteral Feeding to provide 25 kcal/Kg/day
Interventions
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Enteral nutrition with fatty acids
Enteral Feeding to provide 25 kcal/Kg/day
Standard Enteral Nutrition
Enteral Feeding to provide 25 kcal/Kg/day
Eligibility Criteria
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Inclusion Criteria
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.
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.
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Menghua Luo, MD, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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1st City Clinical Emergency Hospital n.a. E.E. Volosevich
Arkhangelsk, , Russia
City Clinical Hospital #2
Krasnodar, , Russia
Krasnoyarsk State Medical University n.a. Prof V.F. Voyno-Yasenetskogo
Krasnoyarsk, , Russia
Central Clinical Hospital #1
Moscow, , Russia
State Novosibirsk Regional Clinical Hospital
Novosibirsk, , Russia
Clinical Medical Unit #1
Perm, , Russia
St. Petersburg Scientific Research Institute of Emergency Care n.a. I.I.Dzhanelidze
Saint Petersburg, , Russia
Republican Clinical Hospital n.a. G.G. Kuvatova
Ufa, , Russia
Central City Hospital #7
Yekaterinburg, , Russia
Countries
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Other Identifiers
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BK54
Identifier Type: -
Identifier Source: org_study_id