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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01250080
First received: November 29, 2010
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Masking: Single Blind (Outcomes Assessor)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitari Son Dureta:

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

Secondary Outcome Measures:
  • -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.

Enrollment: 43
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided by Hospital Universitari Son Dureta

Additional 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
Study First Received: November 29, 2010
Last Updated: November 29, 2010
Health Authority: Spain: Agencia española del medicamento y productos sanitarios (AEMPS)

ClinicalTrials.gov processed this record on May 22, 2013