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Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients

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ClinicalTrials.gov Identifier: NCT00781040
Recruitment Status : Recruiting
First Posted : October 28, 2008
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):

October 27, 2008
October 28, 2008
April 20, 2016
December 2006
December 2016   (Final data collection date for primary outcome measure)
This study evaluates epidemiology, microbiology and outcome of neutropenic fever and severe sepsis in haematological patients with special reference to the kinetics of inflammatory markers. [ Time Frame: Within neutropenic period after treatment ]
This study evaluated epidemiology, microbiology and outcome of neutropenic fever and severe sepsis in haematological patients with special reference to the kinetics of specific inflammatory markers.
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Complete list of historical versions of study NCT00781040 on ClinicalTrials.gov Archive Site
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Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients
Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients
The aim of this study is to find out whether inflammation markers including cardiac markers have predictive value in evaluation of pathogenesis of sepsis in neutropenic haematological patients.
Adult AML and ASCT patients with neutropenic fever. Observation of possible progress to severe sepsis or septic shock. Blood sample collection on days 0-3 (from the beginning of neutropenic fever).
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
Neutropenic patients in haematology ward having neutropenic fever with or without severe sepsis
Sepsis
Other: Severe sepsis vs. non-severe sepsis
To compare these two groups
Other Names:
  • Severe sepsis vs. non-severe sepsis adult AML patients
  • Severe sepsis vs. non-severe sepsis adult ASCT patients
Neutropenic patients
Adult AML and ASCT patients with neutropenic fever.
Intervention: Other: Severe sepsis vs. non-severe sepsis
Vänskä M, Koivula I, Hämäläinen S, Pulkki K, Nousiainen T, Jantunen E, Juutilainen A. High pentraxin 3 level predicts septic shock and bacteremia at the onset of febrile neutropenia after intensive chemotherapy of hematologic patients. Haematologica. 2011 Sep;96(9):1385-9. doi: 10.3324/haematol.2011.044925.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
December 2016
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis: acute myeloid leukaemia
  • age under 70 years
  • neutropenic fever

Exclusion Criteria:

  • age above 70 years
  • no neutropenic fever
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact: Esa Jantunen, M.D, PhD +35817173311 esa.jantunen@kuh.fi
Contact: Sari Hämäläinen, M.D, PhD +35817173311 sari.hamalainen@kuh.fi
Finland
 
 
NCT00781040
KUH5101409
No
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Plan to Share IPD: No
Sari Hamalainen, Kuopio University Hospital
Kuopio University Hospital
Not Provided
Study Director: Esa Jantunen, M.D, PhD Kuopio University Hospital
Kuopio University Hospital
April 2016