Effect of Gutamine Administration in the Innate Immune System Response in ICU Patients.
NCT ID: NCT01250080
Last Updated: 2010-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
43 participants
INTERVENTIONAL
2007-01-31
2008-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Glutamine
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.
Control
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Espen
OTHER
This research prize was funded by Nestle Nutrition Institute and by Fresenius Kabi.
UNKNOWN
Hospital Universitari Son Dureta
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hospital Universitari Son Dureta
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Intensive Care Unit. Hospital Universitario Son Dureta
Palma Mallorca, Balearic Islands, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IB709/06
Identifier Type: -
Identifier Source: org_study_id