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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
Sponsor:
Collaborators:
This work was funded by a grant from the ESPEN Peter Furst Research Prize awarded to Dr J Pérez Bárcena.
This research prize was funded by Nestle Nutrition Institute and by Fresenius Kabi.
Information provided by:
Hospital Universitari Son Dureta

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.


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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Masking: Single (Outcomes Assessor)
Study Start Date : January 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Glutamine 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.



Primary Outcome Measures :
  1. -Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow cytometry

Secondary Outcome Measures :
  1. -To study the functionality of TLR2 and TLR4, monocytes were stimulated with TLR specific agonists and cytokines were measured in cell culture supernatants.
  2. - 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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250080


Locations
Spain
Intensive Care Unit. Hospital Universitario Son Dureta
Palma Mallorca, Illes Balears, Spain, 07014
Sponsors and Collaborators
Hospital Universitari Son Dureta
This work was funded by a grant from the ESPEN Peter Furst Research Prize awarded to Dr J Pérez Bárcena.
This research prize was funded by Nestle Nutrition Institute and by Fresenius Kabi.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jon Pérez Bárcena, Hospital Universitari Son Dureta
ClinicalTrials.gov Identifier: NCT01250080     History of Changes
Other Study ID Numbers: IB709/06
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: September 2008