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

NCT01250782 | Unknown Phase 2 DMC

• 1 other identifier: GlnHSD-001-09
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma ICU Patients

Keywords

Glutamine, trauma patients, infections, mortality

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• ICU Mortality

  ICU mortality measured at 1 month after hospital admission

• SAfety of endovenous administration

  5 days from the beginning of treatment

Study Arms (2)

Physiological Serum

PLACEBO COMPARATOR

Drug: Physiological serum

Glutamine

ACTIVE COMPARATOR

Drug: Glutamine

Interventions

Glutamine DRUG

0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine

Glutamine

Physiological serum DRUG

100 mL of physiological serum indistinguishable from active comparator

Physiological Serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Son Dureta: lead

Study Sites (1)

Hospital Universitario Son Dureta

Palma, Balearic Islands, 07014, Spain

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Glutamine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 1, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 1, 2010

Record last verified: 2010-11

Locations

ES (1)