Trauma ICU Patients
Conditions
Keywords
Glutamine, trauma patients, infections, mortality
Brief summary
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
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.
Interventions
DRUGGlutamine
0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine
100 mL of physiological serum indistinguishable from active comparator
Sponsors
Hospital Universitari Son Dureta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of infections | ICU discharge (median ten days) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| ICU Mortality | ICU mortality measured at 1 month after hospital admission |
| SAfety of endovenous administration | 5 days from the beginning of treatment |
Countries
Spain
Outcome results
None listed