Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients
This study is currently recruiting participants.
Verified January 2013 by Kuopio University Hospital
Sponsor:
Kuopio University Hospital
Information provided by (Responsible Party):
Sari Hamalainen, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00781040
First received: October 27, 2008
Last updated: January 24, 2013
Last verified: January 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 27, 2008 | ||||||||
| Last Updated Date | January 24, 2013 | ||||||||
| Start Date ICMJE | December 2006 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] 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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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00781040 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients | ||||||||
| Official Title ICMJE | Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Neutropenic patients in haematology ward having neutropenic fever with or without severe sepsis |
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| Condition ICMJE | Sepsis | ||||||||
| Intervention ICMJE | Other: Severe sepsis vs. non-severe sepsis
To compare these two groups |
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| Study Group/Cohort (s) | Neutropenic patients
Intervention: Other: Severe sepsis vs. non-severe sepsis |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | December 2014 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Finland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00781040 | ||||||||
| Other Study ID Numbers ICMJE | KUH5101409 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Sari Hamalainen, Kuopio University Hospital | ||||||||
| Study Sponsor ICMJE | Kuopio University Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Kuopio University Hospital | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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