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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Hospital Universitari Son Dureta.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Universitari Son Dureta
ClinicalTrials.gov Identifier:
NCT01250782
First received: November 29, 2010
Last updated: November 30, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention Phase
Trauma ICU Patients
 Drug: Glutamine
Drug: Physiological serum
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
Drug Information available for: Glutamine
U.S. FDA Resources

Further study details as provided by Hospital Universitari Son Dureta:

Primary Outcome Measures:
  • Number of infections [ Time Frame: ICU discharge (median ten days) ] [ Designated as safety issue: No ]
    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:
  • ICU Mortality [ Time Frame: ICU mortality measured at 1 month after hospital admission ] [ Designated as safety issue: No ]
  • SAfety of endovenous administration [ Time Frame: 5 days from the beginning of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: October 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250782

Locations
Spain
Hospital Universitario Son Dureta Recruiting
Palma, Islas Baleares, Spain, 07014
Contact: Jon Pérez-Barcena, MD     34 971 17 51 52     juan.perez@ssib.es    
Principal Investigator: Pedro Marsé-Milla, MD            
Sponsors and Collaborators
Hospital Universitari Son Dureta
  More Information

No publications provided

Responsible Party: Pedro Marsé-Milla, Hospital Universitari Son Dureta
ClinicalTrials.gov Identifier: NCT01250782     History of Changes
Other Study ID Numbers: GlnHSD-001-09
Study First Received: November 29, 2010
Last Updated: November 30, 2010
Health Authority: SPAIN: Agencia Española del Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013