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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01250080
Enrollment
43
Registered
2010-11-30
Start date
2007-01-31
Completion date
2008-09-30
Last updated
2010-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTTotal 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.

OTHERTotal 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.

Sponsors

Espen
CollaboratorOTHER
This research prize was funded by Nestle Nutrition Institute and by Fresenius Kabi.
CollaboratorUNKNOWN
Hospital Universitari Son Dureta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
- 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.
-To study the functionality of TLR2 and TLR4, monocytes were stimulated with TLR specific agonists and cytokines were measured in cell culture supernatants.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026