Back to resultsEffectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study. (GluTrac)
Primary Purpose
Trauma ICU Patients
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Glutamine
Physiological serum
Sponsored by
About this trial
This is an interventional treatment trial for Trauma ICU Patients focused on measuring Glutamine, trauma patients, infections, mortality
Eligibility 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
Sites / Locations
- Hospital Universitario Son DuretaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Physiological Serum
Glutamine
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
ICU Mortality
SAfety of endovenous administration
Full Information
NCT ID
NCT01250782
First Posted
November 29, 2010
Last Updated
November 30, 2010
Sponsor
Hospital Universitari Son Dureta
1. Study Identification
Unique Protocol Identification Number
NCT01250782
Brief Title
Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.
Acronym
GluTrac
Official Title
Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitari Son Dureta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma ICU Patients
Keywords
Glutamine, trauma patients, infections, mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physiological Serum
Arm Type
Placebo Comparator
Arm Title
Glutamine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Glutamine
Intervention Description
0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine
Intervention Type
Drug
Intervention Name(s)
Physiological serum
Intervention Description
100 mL of physiological serum indistinguishable from active comparator
Primary Outcome Measure Information:
Title
Number of infections
Description
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.
Time Frame
ICU discharge (median ten days)
Secondary Outcome Measure Information:
Title
ICU Mortality
Time Frame
ICU mortality measured at 1 month after hospital admission
Title
SAfety of endovenous administration
Time Frame
5 days from the beginning of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital Universitario Son Dureta
City
Palma
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Pérez-Barcena, MD
Phone
34 971 17 51 52
Email
juan.perez@ssib.es
First Name & Middle Initial & Last Name & Degree
Pedro Marsé-Milla, MD
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.
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