Trauma ICU PatientsPhase 2GluTracNCT01250782
Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.
A Phase 2 study testing Glutamine and Physiological serum in people with Trauma ICU Patients, run by Hospital Universitari Son Dureta at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma ICU Patients
- What is being tested?
- Glutamine and Physiological serum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2010to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Son Dureta
Palma, Balearic Islands, 07014
Jon Pérez-Barcena, MD, 34 971 17 51 52, juan.perez@ssib.es
Pedro Marsé-Milla, MD
About this study
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.
- Conditions
- Trauma ICU Patients
- Being tested
- Glutamine, Physiological serum
- Keywords
- Glutamine, trauma patients, infections, mortality
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDrug
0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine
Physiological serumDrug
100 mL of physiological serum indistinguishable from active comparator
| Study group | Role | What they receive |
|---|---|---|
| Physiological Serum | Placebo comparator | Not described Receives: Drug: Physiological serum |
| Glutamine | Active comparator | Not described Receives: Drug: Glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ICU discharge (median ten days)
Secondary outcomes (2)
ICU Mortality
Measured: ICU mortality measured at 1 month after hospital admission
SAfety of endovenous administration
Measured: 5 days from the beginning of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma ICU PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Son Dureta
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250782
- Sponsor's protocol ID
- GlnHSD-001-09
- Acronym
- GluTrac
- Status last verified
- Nov 2010
- First submitted
- 29 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.
- ClinicalTrials.gov ID
- NCT01250782
- Acronym / sponsor ID
- GluTrac / GlnHSD-001-09
- Conditions
- Trauma ICU Patients
- Keywords
- Glutamine, trauma patients, infections, mortality
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Universitari Son DuretaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiological Serum | Placebo comparator | Drug: Physiological serum |
| Glutamine | Active comparator | Drug: Glutamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glutamine0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine | Drug | Glutamine |
| Physiological serum100 mL of physiological serum indistinguishable from active comparator | Drug | Physiological Serum |
Primary outcome
Number of infections
Time frame: 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.
2 secondary outcomes
ICU Mortality
Time frame: ICU mortality measured at 1 month after hospital admission
SAfety of endovenous administration
Time frame: 5 days from the beginning of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glutamine and Physiological serum in people with Trauma ICU Patients, run by Hospital Universitari Son Dureta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of infections (time frame: ICU discharge (median ten days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2010.