Completed

NCT Number: NCT01250080

Effect of Gutamine Administration in the Innate Immune System Response in ICU Patients.

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.

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Key information

Conditions

Moderate to Severe Trauma, as Defined by an Injury Severity Score (ISS) > 12 Points Were Included in the Study.

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive Care Unit. Hospital Universitario Son Dureta

Palma Mallorca, Balearic Islands, 07014, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total Parenteral Nutrition with Glutamine

Dietary 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 glutamine

Other

The control group received a supplemental volume of the basic TPN solution to achieve an isocaloric an isonitrogenated formula with the study group.

Primary outcomes

-Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow cytometry

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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Son Dureta