Effect of Enteral Nutrition Support for Critically Ill Patients

Acute Lung Injury Clinical Trial

Official title:

Effect of Enteral Nutrition Support for Critically Ill Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01464853
• Other study ID #: BK54
• Status: Terminated
• Phase: Phase 3
• First received: November 1, 2011
• Last updated: November 2, 2011
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: March 2011
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Critical Illness
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Distress Syndrome,Adult

Intervention

Other:
• Enteral nutrition with fatty acids
Enteral Feeding to provide 25 kcal/Kg/day
• Standard Enteral Nutrition
Enteral Feeding to provide 25 kcal/Kg/day

Locations

Country	Name	City	State
Russian Federation	1st City Clinical Emergency Hospital n.a. E.E. Volosevich	Arkhangelsk
Russian Federation	Central City Hospital #7	Ekaterinburg
Russian Federation	City Clinical Hospital #2	Krasnodar
Russian Federation	Krasnoyarsk State Medical University n.a. Prof V.F. Voyno-Yasenetskogo	Krasnoyarsk
Russian Federation	Central Clinical Hospital #1	Moscow
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	Republican Clinical Hospital n.a. G.G. Kuvatova	Ufa

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation status improvement		28 days	No
Secondary	Length of ventilation		28 days	No
Secondary	Length of ICU stay		28 days	No
Secondary	Incidence of organ failures		28 days	No
Secondary	Incidence of ventilator-associated pneumonia		28 days	No
Secondary	Mortality		28 days	No
Secondary	Glycemic control		28 days	No
Secondary	Inflammation		28 days	No
Secondary	Vitamin D status		28 days	No