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
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COMPLETED
64 participants
OBSERVATIONAL
2016-09-30
2021-06-30
Brief Summary
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Detailed Description
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CD64 expression on the surface of neutrophils will be determined by fluorescence activated cell sorter (FACS) and with a new bedside test (LeukoDx).
The purpose of the study is to clarify:
1. Is CD64 expression on neutrophils associated with effective antibiotic therapy in critically ill adult patients at risk of sepsis?
2. Is CD64 expression associated with distinct plasma parameters of inflammation?
3. Do the results of the gold standard CD64 determination by FACS correlate with those of a new bedside test (LeukoDx)?
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* critically ill adult patients
* sepsis
* SIRS
* initiation of antibiotic treatment
* patients \< 48 hours after admission on ICU
Exclusion Criteria
* leukopenia \< 1 G/l
* and thrombocytopenia
* rhG-CSF or IFN-gamma therapy up to 1 week before inclusion
* participation in another study receiving drugs or biological within the preceeding 30 days
* recent longterm corticosteroid treatment
* HIV
* patients after organ transplantation treated with immunomodulating drugs
* pregnant patients or after delivery
* life expectancy \< 24 hours
* polytraumatized patients with reanimation on scene, or infest prognosis
* patients under high dose corticosteroids or chemotherapy
18 Years
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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Manfred Weiss
Professor, MD
Principal Investigators
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Manfred Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology, University Hospital Ulm; Ulm, Germany 89075
Locations
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Department of Anaesthesiology, University Hospital Ulm
Ulm, , Germany
Countries
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References
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Barth E, Fischer G, Schneider EM, Wollmeyer J, Georgieff M, Weiss M. Differences in the expression of CD64 and mCD14 on polymorphonuclear cells and on monocytes in patients with septic shock. Cytokine. 2001 Jun 7;14(5):299-302. doi: 10.1006/cyto.2001.0880.
Barth E, Fischer G, Schneider EM, Moldawer LL, Georgieff M, Weiss M. Peaks of endogenous G-CSF serum concentrations are followed by an increase in respiratory burst activity of granulocytes in patients with septic shock. Cytokine. 2002 Mar 7;17(5):275-84. doi: 10.1006/cyto.2002.1010.
Weiss M, Gross-Weege W, Schneider M, Neidhardt H, Liebert S, Mirow N, Wernet P. Enhancement of neutrophil function by in vivo filgrastim treatment for prophylaxis of sepsis in surgical intensive care patients. J Crit Care. 1995 Mar;10(1):21-6. doi: 10.1016/0883-9441(95)90027-6.
Weiss M, Gross-Weege W, Harms B, Schneider EM. Filgrastim (RHG-CSF) related modulation of the inflammatory response in patients at risk of sepsis or with sepsis. Cytokine. 1996 Mar;8(3):260-5. doi: 10.1006/cyto.1996.0035.
Fischer G, Schneider EM, L Moldawer LL, Karcher C, Barth E, Suger-Wiedeck H, Georgieff M, Weiss M. CD64 surface expression on neutrophils is transiently upregulated in patients with septic shock. Intensive Care Med. 2001 Dec;27(12):1848-52. doi: 10.1007/s00134-001-1135-z. Epub 2001 Nov 8.
Other Identifiers
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LeukoDx_CD64_AB_sepsis
Identifier Type: -
Identifier Source: org_study_id