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

Hospital Universitari Son Dureta

Status and phase: Unknown; Phase 2

Conditions: Trauma ICU Patients

Treatments: Drug: Glutamine; Drug: Physiological serum

Study type: Interventional

Funder types: Other

Identifiers

NCT01250782

GlnHSD-001-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Physiological Serum

Placebo Comparator group

Treatment:

Drug: Physiological serum

Glutamine

Active Comparator group

Treatment:

Drug: Glutamine