NCT01250782

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Hospital Universitari Son Dureta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma ICU Patients

Interventions

Type	Name	Description
DRUG	Glutamine	0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine
DRUG	Physiological serum	100 mL of physiological serum indistinguishable from active comparator

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2010-12-01
• Last updated: 2010-12-01

Locations

1 site across 1 country: Spain