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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236703
• Other study ID #: HemoSIRS
• Status: Completed
• Phase: N/A
• First received: November 8, 2010
• Last updated: January 3, 2012
• Start date: March 2010
• Est. completion date: October 2010

Study information

• Verified date: January 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: October 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Sepsis
• SIRS
• Toxemia

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Sysmex Europe GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The second objective is to investigate whether ICIS® and ICPS® could assist in faster antiinfective regim decisions than CRP & PCT.	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 day	No