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Status unknownNCT01250782GluTracUpdated Dec 1, 2010

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

A Phase 2 interventional study of Glutamine and Physiological serum in Trauma ICU Patients, sponsored by Hospital Universitari Son Dureta. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-01.

Sponsored by Hospital Universitari Son Dureta · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Trauma ICU Patients

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Keywords

  • Glutamine, trauma patients, infections, mortality
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's planned enrollment of 150 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

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Lead sponsor

Hospital Universitari Son Dureta is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Placebo comparator
    Physiological Serum

    Drug: Physiological serum

  • Active comparator
    Glutamine

    Drug: Glutamine

Interventions

  • DrugGlutamine

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

  • DrugPhysiological serum

    100 mL of physiological serum indistinguishable from active comparator

06

What researchers measure

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.

    Time frame: ICU discharge (median ten days)

Secondary outcomes

  1. ICU Mortality

    Time frame: ICU mortality measured at 1 month after hospital admission

  2. SAfety of endovenous administration

    Time frame: 5 days from the beginning of treatment

07

Study locations

1 of 1 sites recruiting
  • Hospital Universitario Son Dureta
    Palma, Islas Baleares 07014, Spain
    • Jon Pérez-Barcena, MD · Contact · juan.perez@ssib.es · 34 971 17 51 52
    • Pedro Marsé-Milla, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01250782
Lead sponsor
Hospital Universitari Son Dureta
First posted
Dec 1, 2010
Start date
Oct 2010
Primary completion
Sep 2012 (estimated)
Completion
Oct 2012 (estimated)
Last update
Dec 1, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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