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Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients

This study is currently recruiting participants.
Verified January 2013 by Kuopio University Hospital
Sponsor:
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
History of Changes
  Purpose

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.


Condition Intervention
Sepsis
 Other: Severe sepsis vs. non-severe sepsis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients

Resource links provided by NLM:

MedlinePlus related topics: Fever Sepsis
U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: December 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Neutropenic patients Other: Severe sepsis vs. non-severe sepsis
To compare these two groups

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Neutropenic patients in haematology ward having neutropenic fever with or without severe sepsis

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age above 70 years
  • no neutropenic fever
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781040

Contacts
Contact: Esa Jantunen, M.D, PhD +35817173311 esa.jantunen@kuh.fi
Contact: Sari Hämäläinen, M.D, PhD +35817173311 sari.hamalainen@kuh.fi

Locations
Finland
Kuopio University Hospital Recruiting
Kuopio, Finland
Contact: Sari Hämäläinen, M.D, PhD         sari.hamalainen@kuh.fi    
Sub-Investigator: Auni Juutilainen, M.D, PhD            
Sub-Investigator: Irma Koivula, M.D, PhD            
Active, not recruiting
Kuopio, Finland
Sponsors and Collaborators
Kuopio University Hospital
  More Information

No publications provided by Kuopio University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sari Hamalainen, MD, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00781040     History of Changes
Other Study ID Numbers: KUH5101409
Study First Received: October 27, 2008
Last Updated: January 24, 2013
Health Authority: Finland: Research Ethics Committee, Hospital District of Northern Savo

Keywords provided by Kuopio University Hospital:
Severe sepsis in neutropenic haematological patients

Additional relevant MeSH terms:
Sepsis
Toxemia
Neutropenia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013