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:
Abbott Nutrition
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
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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:
- 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:
- Body temperature less than 36°C or greater than 38°C
- Heart rate > 90 beats per minute
- Tachypnea with > 20 breaths per minute; or an arterial partial pressure of carbon dioxide < 4.3 kPa (32 mmHg)
- White blood cell count < 4000 cells/mm³ or > 12,000 cells/mm³; or the presence of > 10% immature neutrophils.
Exclusion Criteria:
- Dialysis for renal failure
- Unable to initiate Enteral feeding within 48 hours since all inclusion criteria met.
- Anticipated life expectancy less than 24 hours.
- Patient with severe chronic liver disease
- Neuromuscular disease that impairs ability to ventilate without assistance
- Head trauma and/or drowning with a Glasgow coma score of 5
- Receiving intravenous lipid emulsions from parenteral nutrition within 12 hours of baseline.
- Receiving propofol
- Airway reconstructive surgery.
- Malignancy or irreversible disease for which 6-month mortality is greater than 50%.
- Burns greater than 25% total body surface area.
- Unwillingness or inability to utilize the ARDS network ventilation protocol.
- HIV positive.
- Chronic mechanical ventilation.
- Severe, acute pancreatitis.
- Refractory shock
- Congestive heart failure with pulmonary edema as the primary cause of hypoxemia.
- Acute myocardial infarction or cardiac surgery within 7 days.
- Solid organ transplant.
- INR > 5.0 or platelet count < 30,000/mm3 or history of bleeding disorder.
- Intracranial hemorrhage within the past 30 days.
Contacts and Locations
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 Disease Attributes Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on June 18, 2013