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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
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome,Adult

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

First Posted
November 1, 2011
Last Updated
November 2, 2011
Sponsor
Abbott Nutrition
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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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