Status:
UNKNOWN
The Clinical Role of Intravenous Glutamine in Trauma Patients Receiving Enteral Nutrition
Lead Sponsor:
Royal Brisbane and Women's Hospital
Conditions:
Multiple Trauma
Critically Ill
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to investigate if pharmacologically safe dose intravenous glutamine dipeptide supplementation to multiple trauma patients receiving enteral nutrition is associated with im...
Detailed Description
Trauma Patients are characterized by alteration in the immune response, increased exposure to infectious complications, sepsis, and consequently organ failure and death. Glutamine supplementation to p...
Eligibility Criteria
Inclusion
- Age 18-58 years
- Patients admitted with a diagnosis of multiple trauma requiring enteral feeding for \> 48 hours
- Expected length of stay in ICU \> 48 hours
- Has a functional access for enteral tube feeding and a central access for administration of test solution
- Negative Beta HCG (pregnancy test) in females (18-60 years)
Exclusion
- Age \< 18 years
- Significant hepatic failure (Patients with Childs C Cirrhosis)
- Severe renal failure (estimated glomerular filtration rate \[eGFR\] \< 50 ml/min)
- Patients with severe metabolic acidosis (pH \<7.35)
- Not expected to be in the ICU \> 48 hours (due to imminent death)
- Unable to tolerate enteral nutrition within 72 hours
- Enrolment in other ICU intervention study if contraindicated
- Patients in whom parenteral nutrition is required from the outset
- Absolute contraindication to enteral nutrition
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01240291
Start Date
March 1 2011
End Date
June 1 2013
Last Update
May 24 2012
Active Locations (1)
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1
Royal Brisbane & Women's Hospital
Brisbane, Queensland, Australia, 4029