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

NCT01236703 | Completed

• 1 other identifier: HemoSIRS
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SIRS; Sepsis

Keywords

SIRS; Sepsis; hematological infection score

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  a period of 60 days

Secondary Outcomes (1)

• The second objective is to investigate whether ICIS® and ICPS® could assist in faster antiinfective regim decisions than CRP & PCT.

  a period of 60 day

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• ICU patients age \< 18 years
• less than 36h on ICU

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Sysmex Europe GmbH: collaborator

Study Sites (1)

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

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Spies, MD Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr. med. Claudia Spies

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

DE (1)