Moderate to Severe Trauma, as Defined by anNCT01250080
Effect of Gutamine Administration in the Innate Immune System Response in ICU Patients.
A study testing Total Parenteral Nutrition with Glutamine and Total Parenteral Nutrition without glutamine in people with Moderate to Severe Trauma, as Defined by an and Injury Severity Score (ISS) > 12 Points Were Included in the Study., run by Hospital Universitari Son Dureta at 1 site in Spain.
Trial summary
Glutamine is the most abundant nonessential amino acid in the human body. Besides its role as a constituent of proteins and its importance in amino acid transamination, glutamine may modulate immune cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Trauma, as Defined by an, Injury Severity Score (ISS) > 12 Points Were Included in the Study.
- What is being tested?
- Total Parenteral Nutrition with Glutamine and Total Parenteral Nutrition without glutamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2007to Sep 2008
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years (inclusive).
- Moderate to severe trauma, as defined by an Injury Severity Score (ISS) > 12 points were included in the study
- Traumatic patients who required total parenteral nutrition
Who cannot join
- Patients who were under 17 and over 76 years of age,
- Patients whose life expectancy was less than 5 days
- Patientes allergic to glutamine.
- Patients with any basic pathology included any serious immune system condition (diabetes, HIV, lupus, etc.) or who, in their long-term treatment prior to admission to ICU, received corticoids or any other immunosuppressant medication.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Intensive Care Unit. Hospital Universitario Son Dureta
Palma Mallorca, Balearic Islands, 07014
About this study
Glutamine is the most abundant nonessential amino acid in the human body. Besides its role as a constituent of proteins and its importance in amino acid transamination, glutamine may modulate immune cells.
The innate immune system is the first line of host defence against pathogens and in most cases sufficient to eliminate invading microbes. Mammalian Toll-like receptors (TLR) comprise a family of germ line-encoded trans-membrane receptors which activation leads to the induction of inflammatory responses, phagocytosis but also to the development of antigen specific adapative immunity.
It has been postulated though not formally proven yet that glutamine beneficial effect could be due to a positive effect on the innate immune system. Given the importance of TLRs and TLRs-dependent signalling in host defence against infections we hypothesized that glutamine may increase the expression and/or functionality of TLRs which in turn may have beneficial effects to clear infections.
Read the detailed description
Objective: To evaluate whether glutamine supplementation alters the expression and functionality of TLR2 and TLR4 in circulating monocytes of trauma patients admitted to the ICU. Specifically the next variables were measured:
- Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow cytometry
- To study the functionality of TLR2 and TLR4, monocytes were stimulated with TLR specific agonists and cytokines were measured in cell culture supernatants. We determined the concentration of IL-1β, IL-6, TNFα and IL-10 in cell culture supernatants using a bead array ELISA.
- To determine the phagocytic capability of monocytes, live Escherichia coli expressing green fluorescent protein was added to 100 μL of whole blood collected in K2-anticoagulation medium tubes. Bacteria were added at a ratio of 100 bacteria per monocyte. The analyses were carried out in an Epics XL flow cytometer.
- Conditions
- Moderate to Severe Trauma, as Defined by an, Injury Severity Score (ISS) > 12 Points Were Included in the Study.
- Being tested
- Total Parenteral Nutrition with Glutamine, Total Parenteral Nutrition without glutamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Parenteral Nutrition with GlutamineDietary supplement
daily glutamine supplement of 0.35 g/kg weight as N2-L-Alanyl-L-Glutamine (0.5 g/kg/d - Dipeptiven Fresenius Kabi España) during five days.
Total Parenteral Nutrition without glutamineOther
The control group received a supplemental volume of the basic TPN solution to achieve an isocaloric an isonitrogenated formula with the study group.
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Experimental | Not described Receives: Dietary Supplement: Total Parenteral Nutrition with Glutamine |
| Control | Sham comparator | Not described Receives: Other: Total Parenteral Nutrition without glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow cytometry
Secondary outcomes (2)
-To study the functionality of TLR2 and TLR4, monocytes were stimulated with TLR specific agonists and cytokines were measured in cell culture supernatants.
- To determine the phagocytic capability of monocytes, live Escherichia coli expressing green fluorescent protein was added to 100 μL of whole blood collected in K2-anticoagulation medium tubes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startJan 2007
- Primary completionJun 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Trauma, as Defined by anStudies 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 N/A
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Son Dureta
- Sponsor type
- University, hospital or other
- Collaborators
- Espen, This research prize was funded by Nestle Nutrition Institute and by Fresenius Kabi.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250080
- Sponsor's protocol ID
- IB709/06
- Status last verified
- Sep 2008
- First submitted
- 29 Nov 2010
- Last updated
- 30 Nov 2010
- Results posted
- No
Publications
Perez-Barcena J, Crespi C, Regueiro V, Marse P, Raurich JM, Ibanez J, Garcia de Lorenzo-Mateos A, Bengoechea JA. Lack of effect of glutamine administration to boost the innate immune system response in trauma patients in the intensive care unit. Crit Care. 2010;14(6):R233. doi: 10.1186/cc9388. Epub 2010 Dec 24.
PubMed 21184675
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gutamine Administration in the Innate Immune System Response in ICU Patients.
- ClinicalTrials.gov ID
- NCT01250080
- Acronym / sponsor ID
- IB709/06
- Conditions
- Moderate to Severe Trauma, as Defined by an, Injury Severity Score (ISS) > 12 Points Were Included in the Study.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospital Universitari Son DuretaUniversity, hospital or other
- Collaborators
- Espen, This research prize was funded by Nestle Nutrition Institute and by Fresenius Kabi.
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Nov 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.
Glutamine is the most abundant nonessential amino acid in the human body. Besides its role as a constituent of proteins and its importance in amino acid transamination, glutamine may modulate immune cells.
The innate immune system is the first line of host defence against pathogens and in most cases sufficient to eliminate invading microbes. Mammalian Toll-like receptors (TLR) comprise a family of germ line-encoded trans-membrane receptors which activation leads to the induction of inflammatory responses, phagocytosis but also to the development of antigen specific adapative immunity.
It has been postulated though not formally proven yet that glutamine beneficial effect could be due to a positive effect on the innate immune system. Given the importance of TLRs and TLRs-dependent signalling in host defence against infections we hypothesized that glutamine may increase the expression and/or functionality of TLRs which in turn may have beneficial effects to clear infections.
Detailed description
Objective: To evaluate whether glutamine supplementation alters the expression and functionality of TLR2 and TLR4 in circulating monocytes of trauma patients admitted to the ICU. Specifically the next variables were measured:
- Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow cytometry
- To study the functionality of TLR2 and TLR4, monocytes were stimulated with TLR specific agonists and cytokines were measured in cell culture supernatants. We determined the concentration of IL-1β, IL-6, TNFα and IL-10 in cell culture supernatants using a bead array ELISA.
- To determine the phagocytic capability of monocytes, live Escherichia coli expressing green fluorescent protein was added to 100 μL of whole blood collected in K2-anticoagulation medium tubes. Bacteria were added at a ratio of 100 bacteria per monocyte. The analyses were carried out in an Epics XL flow cytometer.
Study design
- Allocation
- Randomised
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Experimental | Dietary Supplement: Total Parenteral Nutrition with Glutamine |
| Control | Sham comparator | Other: Total Parenteral Nutrition without glutamine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 75 years (inclusive).
- Moderate to severe trauma, as defined by an Injury Severity Score (ISS) > 12 points were included in the study
- Traumatic patients who required total parenteral nutrition
Key exclusion criteria (5 listed)
- Patients who were under 17 and over 76 years of age,
- Patients whose life expectancy was less than 5 days
- Patientes allergic to glutamine.
- Patients with any basic pathology included any serious immune system condition (diabetes, HIV, lupus, etc.) or who, in their long-term treatment prior to admission to ICU, received corticoids or any other immunosuppressant medication.
- Pregnant women.
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 |
|---|---|---|
| Total Parenteral Nutrition with Glutaminedaily glutamine supplement of 0.35 g/kg weight as N2-L-Alanyl-L-Glutamine (0.5 g/kg/d - Dipeptiven Fresenius Kabi España) during five days. | Dietary supplement | Glutamine |
| Total Parenteral Nutrition without glutamineThe control group received a supplemental volume of the basic TPN solution to achieve an isocaloric an isonitrogenated formula with the study group. | Other | Control |
Primary outcome
-Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow cytometry
2 secondary outcomes
-To study the functionality of TLR2 and TLR4, monocytes were stimulated with TLR specific agonists and cytokines were measured in cell culture supernatants.
- To determine the phagocytic capability of monocytes, live Escherichia coli expressing green fluorescent protein was added to 100 μL of whole blood collected in K2-anticoagulation medium tubes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
- Derived from this study: PubMed 21184675Perez-Barcena J, Crespi C, Regueiro V, Marse P, Raurich JM, Ibanez J, Garcia de Lorenzo-Mateos A, Bengoechea JA. Lack of effect of glutamine administration to boost the innate immune system response in trauma patients in the intensive care unit. Crit Care. 2010;14(6):R233. doi: 10.1186/cc9388. Epub 2010 Dec 24.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Parenteral Nutrition with Glutamine and Total Parenteral Nutrition without glutamine in people with Moderate to Severe Trauma, as Defined by an and Injury Severity Score (ISS) > 12 Points Were Included in the Study., 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: finished, as of the sponsor's last update on 30 Nov 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow cytometry. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01250080, which also lists 1 linked publication.
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 30 Nov 2010.