Innate Immune Functions of Immature Neutrophils
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ClinicalTrials.gov Identifier: NCT01155674 |
Recruitment Status : Unknown
Verified February 2010 by University Hospital, Geneva.
Recruitment status was: Recruiting
First Posted : July 2, 2010
Last Update Posted : July 2, 2010
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Condition or disease |
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Sepsis SIRS |
Objectives
- Primary objective: To determine the innate immune functions of immature neutrophils in comparison to those from mature neutrophils, sampled from patients with severe sepsis and sepsis shock and in control patients (trauma patients and healthy donors (only mature neutrophils in the latter case)
- Secondary objectives: To determine the fate and span life of immature neutrophils in comparison to mature neutrophils, sampled from patients with severe sepsis and sepsis shock and in control patients (trauma patients and healthy donors (only mature neutrophils in the latter case).
Inclusion criteria
- Patients with severe sepsis or septic shock (according to ACCP/FCCM standard definitions) with > 5% immature neutrophils.
- Patients with a noninfectious systemic inflammatory response syndrome (SIRS), e.g. patients with head trauma or multiple trauma with > 5% immature neutrophils.
- Healthy donors
Exclusion criteria
- Severe immunosuppression (e.g. HIV with < 200 CD4/mm3), treatment with glucocorticoids (> 300 mg hydrocortisone/day) or other immunosuppressive therapy
- Neutropenia (neutrophils < 0.5 G/l).
- Recent chemotherapy or administration of intravenous immunoglobulins within the last 4 weeks.
Endpoints
- Surface expression of receptors of the innate immunity in immature vs. mature neutrophils.
- Production by immature vs. mature neutrophils of inflammatory mediators and reactive oxygen species in response to bacterial agonists.
- Chemotaxis of immature vs. mature neutrophils.
- Phagocytosis of Gram-positive and Gram-negative bacteria by immature vs. mature neutrophils.
- Ex vivo viability and resistance to apoptosis of immature vs. mature neutrophils.
Study Type : | Observational |
Estimated Enrollment : | 60 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Innate Immune Functions of Immature Neutrophils |
Study Start Date : | May 2010 |
Estimated Primary Completion Date : | August 2011 |
Estimated Study Completion Date : | October 2011 |
Group/Cohort |
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Sepsis patients
Patients presenting sepsis
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SIRS patients
Patients presenting with the systemic inflammatory response syndrome
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Healthy subjects
Healthy blood donors
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- Innate immune functions of neutrophils [ Time Frame: 12 months ]
- Surface expression of receptors of the innate immunity in immature vs. mature neutrophils.
- Production by immature vs. mature neutrophils of inflammatory mediators and reactive oxygen species in response to bacterial agonists.
- Chemotaxis of immature vs. mature neutrophils.
- Phagocytosis of Gram-positive and Gram-negative bacteria by immature vs. mature neutrophils.
- Ex vivo viability and resistance to apoptosis of immature vs. mature neutrophils.
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
- Patients with severe sepsis or septic shock
- Patients with a noninfectious systemic inflammatory response syndrome (SIRS)
- Healthy donors
Inclusion Criteria:
- Patients with severe sepsis or septic shock (according to ACCP/FCCM standard definitions) with > 5% immature neutrophils.
- Patients with a noninfectious systemic inflammatory response syndrome (SIRS), e.g. patients with head trauma or multiple trauma with > 5% immature neutrophils.
- Healthy donors
Exclusion Criteria:
- Severe immunosuppression (e.g. HIV with < 200 CD4/mm3), treatment with glucocorticoids (> 300 mg hydrocortisone/day) or other immunosuppressive therapy
- Neutropenia (neutrophils < 0.5 G/l).
- Recent chemotherapy or administration of intravenous immunoglobulins within the last 4 weeks.

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): NCT01155674
Contact: Geneviève Drifte, MD | genevieve.drifte@unige.ch |
Switzerland | |
University Hospitals of Geneva, Intensive Care | Recruiting |
Geneva, Switzerland, 1211 | |
Contact: Jerome Pugin, MD jerome.pugin@unige.ch | |
Sub-Investigator: Geneviève Drifte, MD |
Responsible Party: | Professor Jérôme Pugin, University Hospitals of Geneva |
ClinicalTrials.gov Identifier: | NCT01155674 |
Other Study ID Numbers: |
CER 09-311 |
First Posted: | July 2, 2010 Key Record Dates |
Last Update Posted: | July 2, 2010 |
Last Verified: | February 2010 |
Innate immunity Neutrophils Band forms |