Trauma ICU Patients Clinical Trial
— GluTracOfficial title:
Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | October 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Son Dureta | Palma | Islas Baleares |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Son Dureta |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | ICU Mortality | ICU mortality measured at 1 month after hospital admission | No | |
Secondary | SAfety of endovenous administration | 5 days from the beginning of treatment | Yes |