Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 26, 2013
Last verified: August 2013
  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:


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 2015
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 26, 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
Febrile Neutropenia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014