Trauma patients are characterised by alterations in the immune system, increased exposure to infectious complications, sepsis and potentially organ failure and death. Glutamine supplementation to parenteral nutrition has been proven to be associated with improved clinical outcomes. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. Previous trials have been limited by a small sample size, use of surrogate outcomes or a limited period of supplementation. The aim of this trial is to investigate if intravenous glutamine supplementation to trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications and other secondary outcomes.
Eighty-eight critically ill patients with multiple trauma receiving enteral nutrition will be recruited in this prospective, triple-blind, block-randomised, placebo-controlled clinical trial to receive either 0.5 g/kg/day intravenous undiluted alanyl-glutamine or intravenous placebo by continuous infusion (24 h/day). Both groups will be receiving the same standard enteral nutrition protocol and the same standard intensive care unit care. Supplementation will continue until discharge from the intensive care unit, death or a maximum duration of 3 weeks. The primary outcome will be organ-dysfunction evaluation assessed by the pattern of change in sequential organ failure assessment score over a 10-day period. The secondary outcomes are: the changes in total sequential organ failure assessment score on the last day of treatment, infectious complications during the ICU stay, 60-day mortality, length of stay in the intensive care unit and body-composition analysis.
This study is the first trial to investigate the effect of intravenous alanyl-glutamine supplementation in multiple trauma patients receiving enteral nutrition on reducing severity of organ failure and infectious complications and preservation of lean body mass.
Trial registration number
This trial is registered at http://www.clinicaltrials.gov. NCT01240291.
Glutamine supplementation has demonstrated improved clinical outcomes in patients receiving parenteral nutrition. However, its effect and the best route of administration remain inconclusive for patients receiving enteral nutrition.
Previous trials for patients receiving enteral nutrition had a number of limitations.
This proposed research with other worldwide trials will have implications in improving the practice of glutamine supplementation in critically ill patients.
The results of this trial will provide pilot data for a large multicentre trial to investigate the effect of intravenous glutamine supplementation in multiple trauma patients receiving enteral nutrition on infectious complications and mortality.
Strengths and limitations of this study
This is the first trial to investigate the effect of intravenous glutamine supplementation in trauma patients receiving enteral nutrition on organ failure, infectious complications and body composition.
Supplementation is continued as long as the patient is in the intensive care unit or to a maximum duration of 21 days.
This is a single-centre trial, so it is not powered to investigate the effect of intravenous alanyl-glutamine supplementation on mortality.
Data will not be applicable to trauma patients with severe renal failure or hepatic impairment.
The long-term outcomes (eg, 6-month mortality) are not assessed.