Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients

NCT ID: NCT00781040

Last Updated: 2019-03-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

273 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2019-01-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Sepsis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Neutropenic patients

Adult AML and ASCT patients with neutropenic fever.

Severe sepsis vs. non-severe sepsis

Intervention Type OTHER

To compare these two groups

Interventions

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Severe sepsis vs. non-severe sepsis

To compare these two groups

Intervention Type OTHER

Other Intervention Names

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Severe sepsis vs. non-severe sepsis adult AML patients Severe sepsis vs. non-severe sepsis adult ASCT patients

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* age above 70 years
* no neutropenic fever
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sari Hamalainen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esa Jantunen, M.D, PhD

Role: STUDY_DIRECTOR

Kuopio University Hospital

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status

Kuopio University Hospital

Kuopio, , Finland

Site Status

Countries

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Finland

References

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Vanska M, Koivula I, Hamalainen 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.

Reference Type DERIVED
PMID: 21880642 (View on PubMed)

Other Identifiers

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KUH5101409

Identifier Type: -

Identifier Source: org_study_id

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