Status:
COMPLETED
Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients
Lead Sponsor:
Daren K. Heyland
Collaborating Sponsors:
Fresenius Kabi
Conditions:
Critical Illness
Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether providing high dose glutamine and antioxidants to critically ill patients will be associated with improved survival.
Detailed Description
Background: Critically ill patients experience a degree of hyperinflammation, cellular immune dysfunction, and oxidative stress. Supplementation with key nutrients, like glutamine and antioxidants, i...
Eligibility Criteria
Inclusion
- Mechanically ventilated patients \> or = 18 years old
- 2 or more organ failures related to acute illness
Exclusion
- \> 24 hours from admission to ICU
- Patients who are moribund
- Lack of commitment to aggressive care
- Absolute contraindication to enteral nutrients
- Severe acquired brain injury
- Routine elective cardiac surgery
- Primary admission of burns \> 30% body surface area
- Weight \< 50 kgms or \> 200 kgms
- Pregnant or lactating patients
- Previous randomization in this study
- Enrollment in a related ICU interventional study
- Child's class C liver disease
- Metastatic cancer with life expectancy \< 6 months
- Seizure disorder requiring anticonvulsant medication
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
1223 Patients enrolled
Trial Details
Trial ID
NCT00133978
Start Date
April 1 2005
End Date
May 1 2012
Last Update
January 7 2021
Active Locations (34)
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1
Univ. of Colorado at Denver and Health Sciences Center
Aurora, Colorado, United States, 80045
2
University of Louisville
Louisville, Kentucky, United States, 40202
3
Miami Valley Hospital
Dayton, Ohio, United States, 45409
4
University of Texas
Houston, Texas, United States, 6431