Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study. (GluTrac)
Recruitment status was Recruiting
Recent reports suggest that most beneficial results of glutamine have been obtained with the parenteral administration of high doses of glutamine (0.35 g/Kg/d) and in some special group of patients, such as traumatic patients. Nevertheless total parenteral nutrition is not often used in critically ill patients.
The endovenous administration of the the dipeptide N(2)-L-alanyl-L-glutamine in trauma ICU patients can reduce the number of infections, ICU length of stay and mortality.
This benefit can be achieved independently the type of nutrition (enteral or parenteral nutrition), being a pharmaconutrient.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.|
- Number of infections [ Time Frame: ICU discharge (median ten days) ] [ Designated as safety issue: No ]Based on the results of the ENVIN trial, the median ICU length of stay of trauma patients admitted to the ICU in Spain, is 10 days.
- ICU Mortality [ Time Frame: ICU mortality measured at 1 month after hospital admission ] [ Designated as safety issue: No ]
- SAfety of endovenous administration [ Time Frame: 5 days from the beginning of treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Physiological Serum||
Drug: Physiological serum
100 mL of physiological serum indistinguishable from active comparator
|Active Comparator: Glutamine||
0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine
Objective: To evaluate the efficacy of the endovenous administration endovenous glutamine to reduce the number of infectious complications, mortality and ICU length of stay in trauma ICU patients. To achieve this objective we have designed this pilot study to obtain the necessary data to design a bigger trial in the future.
Other objectives include:
- To evaluate the efficacy of glutamine in different patients regarding their severity: patients with an Injury Severity Score> 25 and patients with lower plasma levels of glutamine.
- To registry the possible adverse events of the endovenous administration of glutamine.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250782
|Hospital Universitario Son Dureta||Recruiting|
|Palma, Islas Baleares, Spain, 07014|
|Contact: Jon Pérez-Barcena, MD 34 971 17 51 52 firstname.lastname@example.org|
|Principal Investigator: Pedro Marsé-Milla, MD|