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

Phase 2

• Conditions: Trauma ICU Patients
• Interventions: Drug: Physiological serum; Drug: Glutamine

• Registration Number: NCT01250782
• Lead Sponsor: Hospital Universitari Son Dureta

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.

Study Timeline

• Study Start: 2010-10
• Status Verified: 2010-11
• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-11-30
• Last Update Submitted: 2010-11-30
• Study First Posted: 2010-12-01
• Last Update Posted: 2010-12-01
• Primary Completion: 2012-09
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiological Serum	Physiological serum	-
Glutamine	Glutamine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
SAfety of endovenous administration	5 days from the beginning of treatment
ICU Mortality	ICU mortality measured at 1 month after hospital admission

Trial Locations

Locations (1)

Hospital Universitario Son Dureta; 🇪🇸 Palma, Islas Baleares, Spain