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Hematological Infection Score Compared to the Hospital Standard for Diagnosis of SIRS or Sepsis on ICU

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236703
First Posted: November 9, 2010
Last Update Posted: January 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sysmex Europe GmbH
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
November 8, 2010
November 9, 2010
January 5, 2012
March 2010
May 2010   (Final data collection date for primary outcome measure)
The primary objective of this study performed according to an observational post-ad-hoc design is to show that the two Sysmex infection scores provide a better performance than CRP & PCT for infection processes thus providing an efficient alternative. [ Time Frame: a period of 60 days ]
Approximately 200 patients will be enrolled in the study. They are followed up until the end of ICU stay or, for a maximum of 60 days. Usually in clinical routine, patients suspected to have an infection process, receive once per day a "full infectiology profile". It consists of CRP, PCT and the Sysmex infection profiles (ICIS/ICPS).
Same as current
Complete list of historical versions of study NCT01236703 on ClinicalTrials.gov Archive Site
The second objective is to investigate whether ICIS® and ICPS® could assist in faster antiinfective regim decisions than CRP & PCT. [ Time Frame: a period of 60 day ]
Approximately 200 patients will be enrolled in the study. They are followed up until the end of ICU stay or, for a maximum of 60 days. Usually in clinical routine, patients suspected to have an infection process, receive once per day a "full infectiology profile". It consists of CRP, PCT and the Sysmex infection profiles (ICIS/ICPS).
Same as current
Not Provided
Not Provided
 
Hematological Infection Score Compared to the Hospital Standard for Diagnosis of SIRS or Sepsis on ICU
Hematological Infection Profile (ICIS/ICPS) Compared to Actual Best Hospital Practice for Differentiation of SIRS and Sepsis and Management of Antiinfective Therapy in ICU Patients

CRP and PCT are not valid parameters of early infection in particularly postoperative patients. (Sanders et al., A&A, June 2006, Vol.102; Katja et al., Shock, February 2001, Vol 15.2) Better detection systems for SIRS and sepsis are urgently required.

ICIS® (Sysmex intensive care infection score) and ICPS® (Sysmex intensive care prognostic score) are two new score-systems depending on detectable cellular response of the innate immune system in human peripheral blood.

The purpose of this observational study is to determine if these scores are superior in early differentiation between non-infectious SIRS and infectious SIRS (sepsis) in postoperative patients. Furthermore, the applicability of the scores for triggering start and ending of anti-infective therapy will be examined.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
All IC department patients (WAN 8i, WAN 14i and WNC S1i Charite Berlin) will be enrolled in the study.
  • SIRS
  • Sepsis
Not Provided
ICU patients
ICU patients (post-operative and none operative patients) will be enrolled in the study. They are followed up until the end of ICU stay or, for a maximum of 60 days.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
October 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • all ICU patients age > 18 years
  • more than 36h on ICU

Exclusion Criteria:

  • ICU patients age < 18 years
  • less than 36h on ICU
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01236703
HemoSIRS
No
Not Provided
Not Provided
Claudia Spies, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Sysmex Europe GmbH
Study Director: Claudia Spies, MD Prof. Charite University, Berlin, Germany
Charite University, Berlin, Germany
January 2012