Effect of Enteral Nutrition Support for Critically Ill Patients

Phase 3

Terminated

• Conditions: Respiratory Distress Syndrome,Adult; Acute Lung Injury
• Interventions: Other: Enteral nutrition with fatty acids; Other: Standard Enteral Nutrition

• Registration Number: NCT01464853
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Status Verified: 2011-03
• Primary Completion: 2011-04
• Study Completion: 2011-05
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-02
• Last Update Submitted: 2011-11-02
• Study First Posted: 2011-11-04
• Last Update Posted: 2011-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Specialized Enteral Nutrition	Enteral nutrition with fatty acids	Enteral Feeding to provide 25 kcal/Kg/day
Standard Enteral Nutrition	Standard Enteral Nutrition	Enteral Feeding to provide 25 kcal/Kg/day

Primary Outcome Measures

Name	Time	Method
Oxygenation status improvement	28 days

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Central City Hospital #7; 🇷🇺 Ekaterinburg, Russian Federation

Republican Clinical Hospital n.a. G.G. Kuvatova; 🇷🇺 Ufa, Russian Federation

State Novosibirsk Regional Clinical Hospital; 🇷🇺 Novosibirsk, Russian Federation

Clinical Medical Unit #1; 🇷🇺 Perm, Russian Federation

St. Petersburg Scientific Research Institute of Emergency Care n.a. I.I.Dzhanelidze; 🇷🇺 St. Petersburg, Russian Federation

Central Clinical Hospital #1; 🇷🇺 Moscow, Russian Federation

1st City Clinical Emergency Hospital n.a. E.E. Volosevich; 🇷🇺 Arkhangelsk, Russian Federation

City Clinical Hospital #2; 🇷🇺 Krasnodar, Russian Federation

Krasnoyarsk State Medical University n.a. Prof V.F. Voyno-Yasenetskogo; 🇷🇺 Krasnoyarsk, Russian Federation