A Phase 3 interventional study of Dipeptiven and normal saline in Multiple Trauma and Critically Ill, sponsored by Royal Brisbane and Women's Hospital. Status unknown at 1 site in Australia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-05-24.
Sponsored by Royal Brisbane and Women's Hospital · Phase 3, Interventional, and Treatment
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
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.
Exclusion Criteria:
Intravenous alanyl-glutamine (0.5 g/kg body weight/day)
Dietary Supplement: Dipeptiven
Intravenous placebo (normal saline; 0.9 %)
Dietary Supplement: normal saline
Intravenous alanyl-glutamine (0.5 g/kg body weight; i.e. 0.35 g L-glutamine / kg body weight; continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks.
Also known as: Fresenius Kabi
0.5 g/kg bod weight /day, continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks
Also known as: NaCl
The change in daily total Sequential Organ Failure Assessment Score (SOFA)each day over 10 days.
The change in daily total SOFA score plotted each day over 10 days, where we will compare the regression slope between the two arms of the study.
Time frame: daily until discharge from intensive care unit, death or maximum duration of 10 days.
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.
Time frame: Last day of treatment
Number of infections that are documented during intensive care unit stay.
Time frame: During intensive care unit stay.
Number of deaths occuring on or before day 60.
Time frame: within 60 days.
Length of stay in intensive care unit.
Time frame: At discharge from intensive care unit.
Length of stay in hospital.
Length of stay in hospital (if delayed discharge due to placement problems, will record from the date the patient is regarded as fit for discharge by medical staff).
Time frame: At hospital discharge.
Number of days on mechanical ventilation.
Time frame: during intensive care unit stay.
Number of days of antibiotic use during intensive care unit stay.
Time frame: during intensive care unit stay.
Fat free mass and fat percentage as a measure of body composition by Bioelectric Impedance analysis (BIA).
Time frame: every 2 days until discharge from the intensive care unit.
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Royal Brisbane and Women's Hospital