The Clinical Role of Intravenous Glutamine in Trauma Patients Receiving Enteral Nutrition (GLINT)
Recruitment status was: Recruiting
|Multiple Trauma Critically Ill||Dietary Supplement: Dipeptiven Dietary Supplement: normal saline||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- The change in daily total Sequential Organ Failure Assessment Score (SOFA)each day over 10 days. [ Time Frame: daily until discharge from intensive care unit, death or maximum duration of 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.
- 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. [ Time Frame: At hospital discharge. ]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).
- 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. ]
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Intravenous alanyl-glutamine (0.5 g/kg body weight/day)
Dietary Supplement: Dipeptiven
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.
Other Name: Fresenius Kabi
Placebo Comparator: normal saline
Intravenous placebo (normal saline; 0.9 %)
Dietary Supplement: normal saline
0.5 g/kg bod weight /day, continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks
Other Name: NaCl
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240291
|Contact: Ruqaiya M Al-Balushi, MSc||+ 61 7 3346 firstname.lastname@example.org|
|Contact: Jennifer Paratz, PhD||+ 61 7 email@example.com|
|Royal Brisbane & Women's Hospital||Recruiting|
|Brisbane, Queensland, Australia, 4029|
|Principal Investigator:||Jeffrey Lipman, MBBCh, MD||Royal Brisbane & Women's Hpsoital|