Effect of Enteral Nutrition Support for Critically Ill Patients
Primary Purpose
Respiratory Distress Syndrome,Adult, Acute Lung Injury
Status
Terminated
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Enteral nutrition with fatty acids
Standard Enteral Nutrition
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome,Adult
Eligibility 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.
Sites / Locations
- 1st City Clinical Emergency Hospital n.a. E.E. Volosevich
- Central City Hospital #7
- City Clinical Hospital #2
- Krasnoyarsk State Medical University n.a. Prof V.F. Voyno-Yasenetskogo
- Central Clinical Hospital #1
- State Novosibirsk Regional Clinical Hospital
- Clinical Medical Unit #1
- St. Petersburg Scientific Research Institute of Emergency Care n.a. I.I.Dzhanelidze
- Republican Clinical Hospital n.a. G.G. Kuvatova
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Specialized Enteral Nutrition
Standard Enteral Nutrition
Arm Description
Enteral Feeding to provide 25 kcal/Kg/day
Enteral Feeding to provide 25 kcal/Kg/day
Outcomes
Primary Outcome Measures
Oxygenation status improvement
Secondary Outcome Measures
Length of ventilation
Length of ICU stay
Incidence of organ failures
Incidence of ventilator-associated pneumonia
Mortality
Glycemic control
Inflammation
Vitamin D status
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01464853
Brief Title
Effect of Enteral Nutrition Support for Critically Ill Patients
Official Title
Effect of Enteral Nutrition Support for Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis indicated significant additional subjects needed to demonsate statistical difference in primary outcome.
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome,Adult, Acute Lung Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Specialized Enteral Nutrition
Arm Type
Experimental
Arm Description
Enteral Feeding to provide 25 kcal/Kg/day
Arm Title
Standard Enteral Nutrition
Arm Type
Active Comparator
Arm Description
Enteral Feeding to provide 25 kcal/Kg/day
Intervention Type
Other
Intervention Name(s)
Enteral nutrition with fatty acids
Intervention Description
Enteral Feeding to provide 25 kcal/Kg/day
Intervention Type
Other
Intervention Name(s)
Standard Enteral Nutrition
Intervention Description
Enteral Feeding to provide 25 kcal/Kg/day
Primary Outcome Measure Information:
Title
Oxygenation status improvement
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Length of ventilation
Time Frame
28 days
Title
Length of ICU stay
Time Frame
28 days
Title
Incidence of organ failures
Time Frame
28 days
Title
Incidence of ventilator-associated pneumonia
Time Frame
28 days
Title
Mortality
Time Frame
28 days
Title
Glycemic control
Time Frame
28 days
Title
Inflammation
Time Frame
28 days
Title
Vitamin D status
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menghua Luo, MD, PhD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
1st City Clinical Emergency Hospital n.a. E.E. Volosevich
City
Arkhangelsk
ZIP/Postal Code
163001
Country
Russian Federation
Facility Name
Central City Hospital #7
City
Ekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
City Clinical Hospital #2
City
Krasnodar
ZIP/Postal Code
350012
Country
Russian Federation
Facility Name
Krasnoyarsk State Medical University n.a. Prof V.F. Voyno-Yasenetskogo
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Central Clinical Hospital #1
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
State Novosibirsk Regional Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Clinical Medical Unit #1
City
Perm
ZIP/Postal Code
614010
Country
Russian Federation
Facility Name
St. Petersburg Scientific Research Institute of Emergency Care n.a. I.I.Dzhanelidze
City
St. Petersburg
ZIP/Postal Code
192442
Country
Russian Federation
Facility Name
Republican Clinical Hospital n.a. G.G. Kuvatova
City
Ufa
ZIP/Postal Code
45005
Country
Russian Federation
12. IPD Sharing Statement
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Effect of Enteral Nutrition Support for Critically Ill Patients
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