Effect of Enteral Nutrition Support for Critically Ill Patients

Abbott

Status and phase: Terminated; Phase 3

Conditions: Acute Lung Injury; Respiratory Distress Syndrome,Adult

Treatments: Other: Standard Enteral Nutrition; Other: Enteral nutrition with fatty acids

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464853

BK54

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Specialized Enteral Nutrition

Experimental group

Description:

Enteral Feeding to provide 25 kcal/Kg/day

Treatment:

Other: Enteral nutrition with fatty acids

Standard Enteral Nutrition

Active Comparator group

Description:

Enteral Feeding to provide 25 kcal/Kg/day

Treatment:

Other: Standard Enteral Nutrition