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

Sponsor

Hospital Universitari Son Dureta (Other)

Overall Status

Unknown status

CT.gov ID

NCT01250782

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2012

Anticipated Study Completion Date :

Oct 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Son Dureta	Palma	Islas Baleares	Spain	07014

Sponsors and Collaborators

Hospital Universitari Son Dureta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01250782

Other Study ID Numbers:

GlnHSD-001-09

First Posted:

Dec 1, 2010

Last Update Posted:

Dec 1, 2010

Last Verified:

Nov 1, 2010

Keywords provided by , ,

Glutamine, trauma patients, infections, mortality

Additional relevant MeSH terms:

Wounds and Injuries

Study Results

No Results Posted as of Dec 1, 2010