Effect of Gutamine Administration in the Innate Immune System Response in ICU Patients.
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|ClinicalTrials.gov Identifier: NCT01250080|
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : November 30, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Moderate to Severe Trauma, as Defined by an Injury Severity Score (ISS) > 12 Points Were Included in the Study.||Dietary Supplement: Total Parenteral Nutrition with Glutamine Other: Total Parenteral Nutrition without glutamine||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||September 2008|
Dietary Supplement: Total Parenteral Nutrition with Glutamine
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.
|Sham Comparator: Control||
Other: Total Parenteral Nutrition without glutamine
The control group received a supplemental volume of the basic TPN solution to achieve an isocaloric an isonitrogenated formula with the study group.
- -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.
- - 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250080
|Intensive Care Unit. Hospital Universitario Son Dureta|
|Palma Mallorca, Illes Balears, Spain, 07014|