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

Trauma ICU Patients Clinical Trial

— GluTrac  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01250782
• Other study ID #: GlnHSD-001-09
• Status: Recruiting
• Phase: Phase 2
• First received: November 29, 2010
• Last updated: November 30, 2010
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: November 2010
• Source: Hospital Universitari Son Dureta
• Contact: n/a
• Is FDA regulated: No
• Health authority: SPAIN: Agencia Española del Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trauma ICU Patients
• Wounds and Injuries

Intervention

Drug:
• Glutamine
0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine
• Physiological serum
100 mL of physiological serum indistinguishable from active comparator

Locations

Country	Name	City	State
Spain	Hospital Universitario Son Dureta	Palma	Islas Baleares

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Son Dureta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	ICU Mortality		ICU mortality measured at 1 month after hospital admission	No
Secondary	SAfety of endovenous administration		5 days from the beginning of treatment	Yes