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Interim analysis indicated significant additional subjects needed to demonsate statistical difference in primary outcome.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specialized Enteral Nutrition | Experimental | Enteral Feeding to provide 25 kcal/Kg/day |
|
| Standard Enteral Nutrition | Active Comparator | Enteral Feeding to provide 25 kcal/Kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral nutrition with fatty acids | Other | Enteral Feeding to provide 25 kcal/Kg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation status improvement | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ventilation | 28 days | |
| Length of ICU stay | 28 days | |
| Incidence of organ failures |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Menghua Luo, MD, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st City Clinical Emergency Hospital n.a. E.E. Volosevich | Arkhangelsk | 163001 | Russia | |||
| City Clinical Hospital #2 |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055370 | Lung Injury |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| D005227 | Fatty Acids |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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| Standard Enteral Nutrition | Other | Enteral Feeding to provide 25 kcal/Kg/day |
|
| 28 days |
| Incidence of ventilator-associated pneumonia | 28 days |
| Mortality | 28 days |
| Glycemic control | 28 days |
| Inflammation | 28 days |
| Vitamin D status | 28 days |
| Krasnodar |
| 350012 |
| Russia |
| Krasnoyarsk State Medical University n.a. Prof V.F. Voyno-Yasenetskogo | Krasnoyarsk | 660022 | Russia |
| Central Clinical Hospital #1 | Moscow | 125367 | Russia |
| State Novosibirsk Regional Clinical Hospital | Novosibirsk | 630087 | Russia |
| Clinical Medical Unit #1 | Perm | 614010 | Russia |
| St. Petersburg Scientific Research Institute of Emergency Care n.a. I.I.Dzhanelidze | Saint Petersburg | 192442 | Russia |
| Republican Clinical Hospital n.a. G.G. Kuvatova | Ufa | 45005 | Russia |
| Central City Hospital #7 | Yekaterinburg | 620109 | Russia |
| D008055 |
| Lipids |