Injury Severity Score (ISS) > 12 Points Were Included in the Study. Clinical Trial
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.
| Status | Completed |
| Enrollment | 43 |
| Est. completion date | September 2008 |
| Est. primary completion date | June 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Masking: Single Blind (Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Spain | Intensive Care Unit. Hospital Universitario Son Dureta | Palma Mallorca | Illes Balears |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitari Son Dureta | This research prize was funded by Nestle Nutrition Institute and by Fresenius Kabi., This work was funded by a grant from the ESPEN Peter Furst Research Prize awarded to Dr J Pérez Bárcena. |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | -Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow cytometry | |||
| Secondary | -To study the functionality of TLR2 and TLR4, monocytes were stimulated with TLR specific agonists and cytokines were measured in cell culture supernatants. | |||
| Secondary | - 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. |