Trauma ICU Patients Clinical Trial
Official 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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment