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

NCT ID: NCT01236703

Last Updated: 2012-01-05

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

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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SIRS Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sysmex Europe GmbH

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia Spies

Univ. Prof. Dr. med. Claudia Spies

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Spies, MD Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

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Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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HemoSIRS

Identifier Type: -

Identifier Source: org_study_id

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