Clinical trial NCT01240291: The Clinical Role of Intravenous Glutamine in Trauma Patients Receiving Enteral Nutrition
Official title: Effect of Intravenous GLutamine Supplementation IN Trauma Patients Receiving Enteral Nutrition Study Protocol (GLINT Study): A Prospective, Blinded, Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Trauma
Critically Ill
Keywords: glutamine
trauma
alanyl-glutamine
Lead sponsor: Royal Brisbane and Women's Hospital
Sponsor class: OTHER_GOV
First posted: 2010-11-15
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 improved clinical outcomes in terms of decreased organ dysfunction, infectious complications, and other secondary outcomes

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 parenteral nutrition is one of the nutritional interventions that have been proven to be associated with improved survival rate, decreased infectious morbidity, costs, intensive care unit, and hospital length of stay. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. A number of trials investigated the beneficial effects of intravenous alanyl-glutamine supplementation in critically ill patients receiving enteral nutrition. However, these trials were: pilot trials, investigated surrogate outcomes, or supplementation was for a short period of time. Therefore, a well designed trial is needed to investigate the effect of intravenous alanyl-glutamine supplementation in critically ill patients with multiple trauma receiving enteral nutrition on major clinical outcomes.

Our hypothesis is that trauma patients receiving standard enteral nutrition supplemented with intravenous alanyl-glutamine will demonstrate improved clinical outcomes compared to patients receiving standard enteral nutrition without supplementation.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: The change in daily total Sequential Organ Failure Assessment Score (SOFA)each day over 10 days.
timeFrame: daily until discharge from intensive care unit, death or maximum duration of 10 days.
Secondary outcomes:
measure: The change in daily total Sequential Organ failure Assessment Score (SOFA) on the last day of treatment as a measure of severity of organ dysfunction.
timeFrame: Last day of treatment
measure: Number of infections that are documented during intensive care unit stay.
timeFrame: During intensive care unit stay.
measure: Number of deaths occuring on or before day 60.
timeFrame: within 60 days.
measure: Length of stay in intensive care unit.
timeFrame: At discharge from intensive care unit.
measure: Length of stay in hospital.
timeFrame: At hospital discharge.
measure: Number of days on mechanical ventilation.
timeFrame: during intensive care unit stay.
measure: Number of days of antibiotic use during intensive care unit stay.
timeFrame: during intensive care unit stay.
measure: Fat free mass and fat percentage as a measure of body composition by Bioelectric Impedance analysis (BIA).
timeFrame: every 2 days until discharge from the intensive care unit.
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
Study officials:
affiliation: Royal Brisbane & Women's Hpsoital
name: Jeffrey Lipman, MBBCh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al Balushi RM, Paratz JD, Cohen J, Banks M, Dulhunty J, Roberts JA, Lipman J. Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial. BMJ Open. 2011 Nov 14;1(2):e000334. doi: 10.1136/bmjopen-2011-000334. Print 2011.