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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01250782
Recruitment Status : Unknown
Verified November 2010 by Hospital Universitari Son Dureta.
Recruitment status was:  Recruiting
First Posted : December 1, 2010
Last Update Posted : December 1, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Trauma ICU Patients Drug: Glutamine Drug: Physiological serum Phase 2

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.
Study Start Date : October 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Number of infections [ Time Frame: 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 :
  1. ICU Mortality [ Time Frame: ICU mortality measured at 1 month after hospital admission ]
  2. SAfety of endovenous administration [ Time Frame: 5 days from the beginning of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01250782

Hospital Universitario Son Dureta Recruiting
Palma, Islas Baleares, Spain, 07014
Contact: Jon Pérez-Barcena, MD    34 971 17 51 52   
Principal Investigator: Pedro Marsé-Milla, MD         
Sponsors and Collaborators
Hospital Universitari Son Dureta

Responsible Party: Pedro Marsé-Milla, Hospital Universitari Son Dureta Identifier: NCT01250782     History of Changes
Other Study ID Numbers: GlnHSD-001-09
First Posted: December 1, 2010    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010

Keywords provided by Hospital Universitari Son Dureta:
Glutamine, trauma patients, infections, mortality

Additional relevant MeSH terms:
Wounds and Injuries