Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.

Conditions
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Trauma ICU Patients

Intervention / Treatment
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* Drug: Glutamine
* Drug: Physiological serum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe trauma, as defined by an Injury Severity Score (ISS) > 10 points were included in the study. Traumatic patients who required enteral or parenteral nutrition during the first 48 hours after hospital admission Written informed consent Exclusion Criteria: patients whose life expectancy was less than 5 days, who were allergic to glutamine, Patients included in any other trial Cirrhotic patients (Child C) Chronic renal failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Physiological Serum<br> | Drug: Physiological serum<br>* 100 mL of physiological serum indistinguishable from active comparator<br>|
| Active Comparator: Glutamine<br> | Drug: Glutamine<br>* 0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infections | 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 discharge (median ten days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Mortality |  | ICU mortality measured at 1 month after hospital admission | 
| SAfety of endovenous administration |  | 5 days from the beginning of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glutamine, trauma patients, infections, mortality