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

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.

Study Overview

• Status: Unknown
• Conditions: Trauma ICU Patients
• Intervention / Treatment: Drug: Physiological serum; Drug: Glutamine

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Islas Baleares
    • Palma, Islas Baleares, Spain, 07014
      • Recruiting
      • Hospital Universitario Son Dureta
      • Contact: Jon Pérez-Barcena, MD; Phone Number: 34 971 17 51 52; Email: juan.perez@ssib.es
      • Principal Investigator: Pedro Marsé-Milla, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glutamine	Drug: Glutamine; 0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine
Placebo Comparator: Physiological Serum	Drug: Physiological serum; 100 mL of physiological serum indistinguishable from active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitari Son Dureta

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: November 29, 2010
• First Submitted That Met QC Criteria: November 30, 2010
• First Posted (Estimate): December 1, 2010

Study Record Updates

• Last Update Posted (Estimate): December 1, 2010
• Last Update Submitted That Met QC Criteria: November 30, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Glutamine, trauma patients, infections, mortality
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: GlnHSD-001-09