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

This study has been completed.
Sponsor:
Collaborator:
Sysmex Europe GmbH
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01236703
First received: November 8, 2010
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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.


Condition
SIRS
Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 207
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All IC department patients (WAN 8i, WAN 14i and WNC S1i Charite Berlin) will be enrolled in the study.

Criteria

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
  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: NCT01236703

Locations
Germany
Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Sysmex Europe GmbH
Investigators
Study Director: Claudia Spies, MD Prof. Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Claudia Spies, Univ. Prof. Dr. med. Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01236703     History of Changes
Other Study ID Numbers: HemoSIRS
Study First Received: November 8, 2010
Last Updated: January 3, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
SIRS
Sepsis
hematological infection score

Additional relevant MeSH terms:
Infection
Sepsis
Toxemia
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 29, 2014