Clinical trial NCT01464853: Effect of Enteral Nutrition Support for Critically Ill Patients
Official title: Effect of Enteral Nutrition Support for Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Respiratory Distress Syndrome,Adult
Acute Lung Injury
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Oxygenation status improvement
timeFrame: 28 days
Secondary outcomes:
measure: Length of ventilation
timeFrame: 28 days
measure: Length of ICU stay
timeFrame: 28 days
measure: Incidence of organ failures
timeFrame: 28 days
measure: Incidence of ventilator-associated pneumonia
timeFrame: 28 days
measure: Mortality
timeFrame: 28 days
measure: Glycemic control
timeFrame: 28 days
measure: Inflammation
timeFrame: 28 days
measure: Vitamin D status
timeFrame: 28 days
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: 1st City Clinical Emergency Hospital n.a. E.E. Volosevich
city: Ekaterinburg
country: Russian Federation
facility: Central City Hospital #7
city: Krasnodar
country: Russian Federation
facility: City Clinical Hospital #2
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical University n.a. Prof V.F. Voyno-Yasenetskogo
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital #1
city: Novosibirsk
country: Russian Federation
facility: State Novosibirsk Regional Clinical Hospital
city: Perm
country: Russian Federation
facility: Clinical Medical Unit #1
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Scientific Research Institute of Emergency Care n.a. I.I.Dzhanelidze
city: Ufa
country: Russian Federation
facility: Republican Clinical Hospital n.a. G.G. Kuvatova
Study officials:
affiliation: Abbott Nutrition
name: Menghua Luo, MD, PhD
role: STUDY_CHAIR
References: