Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiological Serum | Placebo Comparator |
| |
| Glutamine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutamine | Drug | 0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine |
| |
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Son Dureta | Recruiting | Palma | Balearic Islands | 07014 | Spain |
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005973 | Glutamine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Physiological serum |
| Drug |
100 mL of physiological serum indistinguishable from active comparator |
|
| D021542 | Amino Acids, Neutral |