Effect of Enteral Nutrition Support for Critically Ill Patients

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.

Study Overview

• Status: Terminated
• Conditions: Acute Lung Injury; Respiratory Distress Syndrome,Adult
• Intervention / Treatment: Other: Enteral nutrition with fatty acids; Other: Standard Enteral Nutrition

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk, Russian Federation, 163001
    • 1st City Clinical Emergency Hospital n.a. E.E. Volosevich
  • Ekaterinburg, Russian Federation, 620109
    • Central City Hospital #7
  • Krasnodar, Russian Federation, 350012
    • City Clinical Hospital #2
  • Krasnoyarsk, Russian Federation, 660022
    • Krasnoyarsk State Medical University n.a. Prof V.F. Voyno-Yasenetskogo
  • Moscow, Russian Federation, 125367
    • Central Clinical Hospital #1
  • Novosibirsk, Russian Federation, 630087
    • State Novosibirsk Regional Clinical Hospital
  • Perm, Russian Federation, 614010
    • Clinical Medical Unit #1
  • St. Petersburg, Russian Federation, 192442
    • St. Petersburg Scientific Research Institute of Emergency Care n.a. I.I.Dzhanelidze
  • Ufa, Russian Federation, 45005
    • Republican Clinical Hospital n.a. G.G. Kuvatova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Oxygenation status improvement	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	28 days
Length of ICU stay	28 days
Incidence of ventilator-associated pneumonia	28 days
Length of ventilation	28 days
Incidence of organ failures	28 days
Glycemic control	28 days
Inflammation	28 days
Vitamin D status	28 days

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Menghua Luo, MD, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: November 1, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 4, 2011

Study Record Updates

• Last Update Posted (Estimate): November 4, 2011
• Last Update Submitted That Met QC Criteria: November 2, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: BK54