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

NCT01250080 | Completed

• 1 other identifier: IB709/06
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• -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.

Study Arms (2)

Glutamine

EXPERIMENTAL

Dietary Supplement: Total Parenteral Nutrition with Glutamine

Control

SHAM COMPARATOR

Other: Total Parenteral Nutrition without glutamine

Interventions

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.

Glutamine

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.

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Son Dureta: lead
• Espen: collaborator
• This research prize was funded by Nestle Nutrition Institute and by Fresenius Kabi.: collaborator

Study Sites (1)

Intensive Care Unit. Hospital Universitario Son Dureta

Palma Mallorca, Balearic Islands, 07014, Spain

Location

Related Publications (1)

• Perez-Barcena J, Crespi C, Regueiro V, Marse P, Raurich JM, Ibanez J, Garcia de Lorenzo-Mateos A, Bengoechea JA. Lack of effect of glutamine administration to boost the innate immune system response in trauma patients in the intensive care unit. Crit Care. 2010;14(6):R233. doi: 10.1186/cc9388. Epub 2010 Dec 24.

  PMID: 21184675 DERIVED

MeSH Terms

Interventions

Parenteral Nutrition, Total; Glutamine

Intervention Hierarchy (Ancestors)

Parenteral Nutrition; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: November 30, 2010
• Study Start: January 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 30, 2010

Record last verified: 2008-09

Locations

ES (1)